The Cabinet Committee on Economic Affairs approved the proposal of the Ministry of Health & Family Welfare for establishment of Integrated Vaccines Complex (IVC) at Chengalpattu, Kanchipuram district (Tamil Nadu) at an estimated cost of Rs. 594 crore (USD 120 million). The project is planned to be completed by 2015. M/s HLL Lifecare Limited has formed a 100% subsidiary company, HLL Biotech Limited for implementing the project. HLL Biotech Limited corporate office is located at TICEL Biopark (Module 013, 014, 015) at TICEL Biopark, Taramani, Chennai, Tamilnadu.
Post: Assistant Manager, Marketing Executives, Deputy Manager, Research Associate, Manager
POSTS
Assistant Manager (Pharmacovigilance)
-Assistant Manager (Bacterial Vaccine Formulation)
-Deputy Manager/Assistant Manager (Process & Technology Sourcing)
-Research Associate (Process & Technology Sourcing)
-Deputy Manager (Production HIB)
-Assistant Manager (Production HIB)
-Assistant Manager (Production BCG)
-Research Associate (Production BCG)
-Deputy Manager (Documentation)
-Assistant Manager (Validation)
Assistant Manager (Pharmacovigilance)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Pharmacovigilance
Grade: E0
Scale of pay: 12,600 – 32,500 (Minimum CTC: 5.0 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai / Chengalpattu
Job Description:
- Assisted in the preparation of all required Clinical study start up documents
- Preparation other study documents like CRF, Dairy cards, and study flow charts.
- Assisted in selection of Sites
- Preparation of Trial Master File (TMF), Investigator Site File (ISF), and Study Site File (SSF)
- Conducted the Pre-study visit in the selection process.
- Preparation of IRB/IEC dossiers
- Assisted in preparation of budgets and schedule of budgets.
- Determine, order, ship and track investigational drug supplies.
- Conducting of study initiation visits.
- Conducting of Interim monitoring visits
- Maintain and track study data
- Reporting of SAEs to NRAs and other IECs
- Conduct study close out visits
- Perform post study follow-ups
- Assisted while data entry by data monitoring people
- Assisted in data analysis which will be done by the SAS analyst
- Assisted in the preparation of clinical trial report
- 40-60% Travel
Post Qualification Experience:
Essential Experience:
- Minimum 1 year experience in Clinical trial operations in Bio-Technology/Pharmaceutical Industries.
- Communicate effectively verbally and in writing
- Work with cross-functional teams
Desirable Experience:
Monitoring of Clinical trials.
Age: 35
Educational Qualification
Essential: M.Sc / M.Pharm.
Specialisation: M. Pharmacy (Pharmacology/ Pharmaceutics)/ M.Sc. (Biotechnology/ Clinical trials)
Experience: 1 Yrs
Application end date: 16-09-2015
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Assistant Manager (Bacterial Vaccine Formulation)
No. of Posts: 2
Category: SC, ST, OBC, GENERAL
Department: Poduction (Formulation & Filling)
Grade: E0
Scale of pay: 12,600 – 32,500 (Minimum CTC: 5.0 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai / Chengalpattu
Job Description:
- Experience in Bacterial Vaccine formulation (Human Vaccines different combination)
- Experience in Process equipment validation, Process validation and cleaning validation
- Experience in operation and Troubleshooting & Vial washing depyrogenation and blending vessels
- Preparation of Documents related to formulation activities like MFR and Dossiers.
- Preparation and execution of SOP’s, Protocols and validation documentation
- Experience in handling of deviations, Change controls, CAPA, RA and Supply chain management
Post Qualification Experience:
Essential Experience:
Minimum 1 Years’ experience in Human Vaccines formulation and filling area.
Desirable Experience:
Minimum 1 Year experience in WHO pre-qualified Human Vaccines Formulation & Filling facility
Age: 35
Educational Qualification
Essential: M.Sc / B.Tech (Biotech)
Specialisation: M. Sc (Life Science)
Experience: 1 Yrs
Application end date: 16-09-2015
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Marketing Executives
No. of Posts: 15
Category: SC, ST, OBC, GENERAL
Department: Marketing
Grade: NA
Scale of pay: NA
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Contract
Place of Posting: Chennai / Any where in Kerala / Tamilnadu
Job Description:
- Driving and managing sales in the assigned area. Build and developing team, CRM, Market Intelligence and Effective Implementation of strategies.
- Responsible for achievement of sales budget as per monthly/quarterly/yearly sales plan.
- Implementation of sales and marketing strategies
- Focus on weak areas of the assigned territory and improve it to achieve sales and marketing budget.
- Creating network of franchisees and own CC to reach clients and excellent services.
- With the help of seniors bridge the gap in budget and performance to earn incentives.
- Coordinate with logistics and operations.
- Ensure timely recovery of money and avoid bad debts
- Competitors and own strategic feedback to management.
- Coordination with other teams to create a good atmosphere.
Post Qualification Experience:
Candidates having minimum 1 yr to 8 yrs of experience in Vaccine / Pharma sales.
Depending upon the qualification & experience Positions shall be offered.
Age: 40
Educational Qualification
Essential: Any Under Graduation / Any Post Graduation
Specialisation: Any Undergraduate degree / Any Master Degree
Experience: 1 year to 8 years Yrs
Application end date: 16-09-2015
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Deputy Manager/Assistant Manager (Process & Technology Sourcing)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Process & Technology Sourcing
Grade: E1/E0
Scale of pay: 16,400 – 40,500 / 12,600 – 32,500 (Minimum CTC: 6.60 Lacs (DM) / 5.0 Lacs (AM) Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai
Job Description:
- Technology transfer documentation, review of technology transfer agreements, support vaccine development activities.
- Co-ordination with team leaders of each vaccine & technology transfer organisations for preparing the documents.
- Co-ordination of steering committee meetings for technology transfer.
- Preparation of process flow, production program
- Selection of equipment for manufacturing, filing and lyophilisation of vaccine, seed revival and preparation of master and working seed.
Post Qualification Experience:
Essential Experience:
1 years experience in research & development / manufacturing of Bacterial / viral vaccine.
Age: 40
Educational Qualification
Essential : M.ScM.Pharm. / B.Tech (Biotech)
Specialisation: Microbiology / Biochemistry / Biotech / Medical Microbiology / Medical Biochemistry / Medical Biotech / Biotech / Pharm.
Experience: 3 yrs (DM) / 1 yr (AM) Yrs
Application end date: 16-09-2015
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Research Associate (Process & Technology Sourcing)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Process & Technology Sourcing
Grade: E0
Scale of pay: 12,600 – 32,500 (Minimum CTC: 5.0 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai
Job Description:
- Technology transfer documentation, review of technology transfer agreements, support vaccine development activities.
- Co-ordination with team leaders of each vaccine & technology transfer organisations for preparing the documents.
- Co-ordination of steering committee meetings for technology transfer.
Post Qualification Experience:
Essential Experience:
For Research Associate post minimum 1 years# experience in research & development / manufacturing of BCG vaccine.
Age: 35
Educational Qualification
Essential: B.E.M.Sc / M.Pharm.
Specialisation: M.Sc (Microbiology / Biochemistry/Biotech/Medical Microbiology/Medical Biochemistry/Medical Biotech) / M.Pharm / B.Tech(Biotech)
Experience: 1 Yrs
Application end date: 16-09-2015
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Manager (Production HIB)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Production HIB
Grade: E2
Scale of pay: 20,600 – 46,500 (Minimum CTC: 8.30 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai
Job Description:
- To execute all conjugation of polysaccharide related experiments.
- To execute purification & Characterization of conjugate.
- To coordinate the laboratory and manufacturing operations in relation to QC activities.
Post Qualification Experience:
Essential Experience:
Minimum 5 years of exprience in process development and/or manufacturing of bacterial vaccines.
Desirable Experience:
Experience in polysaccharide vacccines, prefereably HIB polysaccharide conjucation and purification
Age: 40
Educational Qualification
Essential: M.Sc / M.Pharm.
Specialisation: Biochemistry/Biotech/Microbiology / Biotech / M.Tech (Biotech)
Experience: 5 Yrs
Application end date: 16-09-2015
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Deputy Manager (Production HIB)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Production HIB
Grade: E1
Scale of pay: 16,400 – 40,500 (Minimum CTC: 6.60 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai
Job Description:
- To handle all conjugation of polysaccharide related experiments.
- To handle purification & Characterisation of conjugate.
- To coordinate the laboratory and manufctuing operations in relation to QC activities.
Post Qualification Experience:
Essential Experience:
Minimum 3 years of exprience in process development and/or manufacturing of bacterial vaccines.
Desirable Experience:
Experience in polysaccharide vacccines, prefereably HIB polysaccharide conjucation and purification
Age: 40
Educational Qualification
Essential: M.ScM.Pharm. / B.Tech (Biotech)
Specialisation: Biochemistry/Biotech/Microbiology/Biotech
Desirable: M.Tech (Biotech)
Experience: 3 Yrs
Application end date: 16-09-2015
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Assistant Manager (Production HIB)
No. of Posts: 2
Category: SC, ST, OBC, GENERAL
Department: Production HIB
Grade: E0
Scale of pay: 12,600 – 32,500 (Minimum CTC: 5.0 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai
Job Description:
- To handle all bacterial culture experiements from fermentation to crude polysaccharide isolation.
- To handle purification of polysaccharide and monitor the characterization in coordination with QC.
Post Qualification Experience:
Essenyial Experience
Minimum 1 yr experience in process development and / or manufacturing of bacterial vaccines.
Desirable Experience:
Experience in polysaccharide vaccines process development and/or manufacturing
Age: 35
Educational Qualification
Essential: M.ScM.Pharm. / B.Tech (Biotech)
Specialisation: Biochemistry/Biotech/Microbiology / Biotech
Desirable: M.Tech (Biotech)
Experience: 1 Yrs
Application end date: 16-09-2015
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Assistant Manager (Production BCG)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Production BCG
Grade: E0
Scale of pay: 12,600 – 32,500 (Minimum CTC: 5.0 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai
Job Description:
- Establishment of process development lab for BCG Vaccine
- Preparation of SOPs - formulation, filling & lyophilization of BCG Vaccine
- Preparation of SOP, DQ - filling machine & lyophilizer
- Lab scale process development - BCG Vaccine (Upstream and Downstream)
Post Qualification Experience:
Essential Experience:
Minimum 1 year of experience in production (culture & incubation, harvest and downstream process), media preparation, filling and lyphilization of BCG vaccine.
Desirable Experience:
Experience in operation of folling machine and lyophilizer for production of BCG Vaccine.
Age: 35
Educational Qualification
Essential: B.E. / M.Sc
Specialisation: M.Sc in Microbiology / Biochemistry / Biotechnology / M.Pharm / B.Tech(Biotech)
Experience: 1 Yrs
Application end date: 16-09-2015
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Research Associate (Production BCG)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Production BCG
Grade: E0
Scale of pay: 12,600 – 32,500 (Minimum CTC: 5.0 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai/ Chengalpattu
Job Description:
- Establishment of process development lab for BCG Vaccine
- Preparation of SOPs - formulation, filling & lyophilization of BCG Vaccine
- Preparation of SOP, DQ - filling machine & lyophilizer
- Lab scale process development - BCG Vaccine (Upstream and Downstream)
Post Qualification Experience:
Essential Experience:
Minimum 1 year of experience in production (culture & incubation, harvest and downstream process), media preparation, filling and lyphilization of BCG vaccine.
Desirable Experience:
Experience in operation of folling machine and lyophilizer for production of BCG Vaccine.
Age: 35
Educational Qualification
Essential: M.ScM.Pharm. / B.Tech (Biotech)
Specialisation: Microbiology / Biochemistry / Biotechnology / M.Pharm / Biotech
Experience: 1 Yrs
Application end date: 16-09-2015
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Deputy Manager (Validation)
No. of Posts: 2
Category: SC, ST, OBC, GENERAL
Department: Quality Assurance
Grade: E1
Scale of pay: 16,400 – 40,500 (Minimum CTC: 6.60 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai/ Chengalpattu
Job Description:
- Write, review for approval of site and departmental VMP and VP and other site high level documents.
- Write, review for approval of site and departmental CMP and assess/ qualify third party for calibration.
- Document review for approval of URS, DQ, Protocol {IQ, OQ, PQ}, validation batch records, change request, Risk Assessments, Reports, Test plans/ Transfers, laboratory documents and SOPs.
- To participate and coordinate with cross functional teams (CFTs) in carrying out FAT, SAT and qualification of systems and equipment’s as per the defined approved procedure/s.
- Experience in CQV aspects wrt. facility, systems and equipment’s
- Prepare, revise and / or review of validation SOPs /Study protocols for approval.
- To organise team in execution of activities related to Commissioning, Validation and Qualification plan.
- Work with validation and laboratory staff in managing investigation, deviation, CAPAs and other quality events.
- To review the method validation/ verification protocols and all other miscellaneous studies.
- To coordinate with the cross functional teams (CFTs) for any unresolved issues and to resolve open points related to validation issues.
- Identify and impart training module on a timely manner related to qualification and validation.
Post Qualification Experience:
Essential Experience:
Should have thorough knowledge in QA system and faced regulatory audits in sterile/biological/vaccine facility related to validation conformance to NRA/WHO/USFDA. Preferably executed activities related to Commissioning, Validation and Qualification on the shop floor, particularly in the production areas (Bulk and Fill finish) and monitor processes for compliance to cGMP standards and should be capable of leading a team.
Desirable Experience:
Candidate shall be preferred having worked/ gained good experiences and understanding in green field projects.
The candidate should have good exposure on all validation activities in Sterile facility, Sterilizer/Autoclave/Tunnel/DHS, Filling Line, AHU/HVAC, Lyophilizer, Fermentors, CIP/SIP, Clean Room Equipments, Water system, Compressed gases, Media fill, Process validation, Cleaning validation, Computer System Validation, lab equipment’s Qualification and Analytical method validation etc. will be preferred.
Age: 40
Educational Qualification
Essential: M.Sc / M.Pharm.
Specialisation: Life Science
Experience: 3 Yrs
Application end date: 16-09-2015
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Deputy Manager (Documentation)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Quality Assurance
Grade: E1
Scale of pay: 16,400 – 40,500 (Minimum CTC: 6.60 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai/ Chengalpattu
Job Description:
- To define procedure for control/issuance/retrieval and retention of all QMS documents conformance to cGDP and to plan and co-ordinate gap analysis exercises and provide advice on bridging the gap.
- Timely tracking of quality documents through follow ups and to intimate and coordinate with Cross function team (CFT) for revision within the stipulated timelines defined as per the approved procedure.
- To Supervise and direct quality section staff reporting to this position and to ensure the timely and accurate completion of quality related documentation.
- Plan and co-ordinate for quality documents related to quality audits with the relevant CFT and review the same for final approval.
- Ensure that the procedures and controls on documentation prescribed by the Quality management system are in place and implemented.
- Identify the required documentation for submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Document reviewal and archival of URS, DQ, Protocol { IQ, OQ, PQ}, validation batch records, change request, Risk Assessments, Reports, Test plans/ Transfers, laboratory documents as per approved procedures.
- To define procedure and ensure the destruction of quality documents as per cGDP.
- To coordinate internally with CFT for compilation of documents required PSF or dossiers required for regulatory submission.
- To develop system for induction/impart training for employees and conduct periodic training through identification of training needs.
- To define and develop a system of identifying trainers internally with suitable evaluation and qualification procedure of all disciplines.
Post Qualification Experience:
Essential Experience:
The candidate should have a thorough knowledge and understanding in identifying and developing the essential documentation/ quality management system as per the regulatory requirement and should be capable of leading a team.
Should have worked in documentation team and faced regulatory audits NRA/WHO/USFDA.
Desirable Experience:
Candidate shall be preferred having worked/gained good experiences in establishing Documentation system/s in green field projects.
Age: 40
Educational Qualification
Essential: M.Sc / M.Pharm.
Specialisation: Life Science
Desirable: Post Graduate in Life Science with relevant post qualification experience
Experience: 3 Yrs
Application end date: 16-09-2015
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Assistant Manager (Validation)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Quality Assurance
Grade: E0
Scale of pay: 16,400 – 40,500 (Minimum CTC: 6.60 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai
Job Description:
- To execute and support quality assurance activities related to commissioning, qualification and validation of facilities and equipment of biological manufacturing & testing facilities.
- Should be conversant in study protocol preparation related to Process validation/ verification, cleaning process validation/ verification, equipment, facility, and utility qualification/ caliberation, Microbiological/ analytical method validation, Miscellaneous validations like media fill, hold time studies, GxP etc.., requalification at site.
- Good understanding of Engineering fundamentals and instrumentation.
- Preparation of Documents (SOPs, Validation/ calibration documents) with good documentation skills.
Post Qualification Experience:
Essential Experience:
Should have thorough knowledge in QA system and faced regulatory audits in sterile/biological/vaccine facility related to validation conformance to NRA/WHO/USFDA.
Desirable Experience:
Candidate shall be preferred having worked/ gained good experiences and understanding in green field projects.
The candidate having good exposure on all validation activities in Sterile facility, Sterilizer/Autoclave/Tunnel/DHS, Filling Line, AHU/HVAC, Lyophilizer, Fermentors, CIP/SIP, Clean Room Equipments, Water system, Compressed gases, Media fill, Process validation, Cleaning validation, Computer System Validation, lab equipment’s Qualification and Analytical method validation etc. will be preferred.
Age: 35
Educational Qualification
Essential: M.ScM.Pharm. / B.Tech (Biotech)
Specialisation: Lifescience / Pharma / Biotech
Experience: 1 Yrs
Application end date: 16-09-2015
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Deputy Manager (QMS)
No. of Posts: 2
Category: SC, ST, OBC, GENERAL
Department: Quality Assurance
Grade: E1
Scale of pay: 16,400 – 40,500 (Minimum CTC: 6.60 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: Chennai/ Chengalpattu
Job Description:
- To define SOP related to QMS documents, Site master file with implementation and ensuring the training to all Cross function team.
- To record all Quality internal audits as required and ensure quality audit findings and recommendations are compiled and monitored for completion.
- To conduct regular follow up through metrics and update the status of QMS activities to immediate seniors (Change control, Event, Deviation, CAPA, DMF, Market complaint etc.) during internal QA review meeting.
- To monitor and track periodically for in and out of material in Warehouse and verify its compliance as per Good store practice (cGSP).
- To monitor the validation activities (Process validation, Equipment qualification, A.H.U. & Area qualification, Water system validation, Compressed air validation & Cleaning validation) with proper documentation work.
- To record the Market compliant and participate investigation on the compliant and generate investigation report.
- To carryout RCA/OOS investigation and defining the appropriate CAPA and review the implemented CAPA prior to their closure.
- To coordinate and arrange for change control review panels for evaluation of change proposals, capturing action plan and their closing.
- To participate in process of the vendor assessment identified for process and testing requirements and tracking the schedule for periodic reviews as per approved procedure.
- To compile data for trend analysis of quality parameters required for APR.
- To participate and undertake revision on QMS procedure observed during periodic review to assess continued suitability and areas of possible improvement.
Post Qualification Experience :
Essential Experience:
The candidate should have a knowledge and understanding in identifying and developing the essential quality management system as per the regulatory requirement.
Should have worked and faced regulatory audits NRA/WHO/USFDA.
Desirable Experience:
Candidate shall be preferred having worked/gained experience in establishing QMS in green field projects.
Age: 40
Educational Qualification
Essential: M.Sc / M.Pharm.
Specialisation: M.Sc (Life Science)
Experience: 3 Yrs
Application end date: 16-09-2015
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Assistant Manager (Product Testing)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Quality Control
Grade: E0
Scale of pay: 12,600 – 32,500 (Minimum CTC: 5.0 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variable Dearness Allowance, Perks at 47% of the basic pay as per "cafeteria" approach are admissible. Other benefits viz; Earned Leave (incl.Leave Encashment), Casual Leave, Sick Leave, Medical benefits for self & family, Provident Fund, Gratuity, Uniform and HRA / Leased Accommodation etc. will be admissible as per the Company rules.
Nature of Employment: Permanent
Place of Posting: 1
Job Description:
- Should have working experience in testing related of Hepatitis B, Hib and Pentavalent vaccine.
- Should have working experience in release and stability testing related to bulk, blend and finished product/s.
- Daily verification/ calibration of the lab equipment’s and updating of log books.
- Preparation of SOPs/ STPs/Protocols and record sheets.
- To coordinate for various activities related to training, safety, general administration and inter department activity.
- Execution of method qualification/ validation/ transfer cross over studies.
- To ensure all the tests are performed as per cGLP norms with necessary documentation.
- To ensure timely batch release and stability
- Possess the knowledge in regulatory guidelines.
- Assist in purchase and installation of laboratory equipment/s, chemicals, reagents and consumables.
- Troubleshoot instrument within area of expertise.
- To maintain the Training record of SOP & updating the training matrix by regular interval and submit the records.
Post Qualification Experience :
Essential Experience:
Should have good experience in product testing pertaining to bacterial/ recombinant vaccines.
Should have participated in regulatory audits NRA/WHO/USFDA. Should be capable of leading a team .
Desirable Experience:
Candidate shall be preferred having worked/ gained good experiences in handling the equipment’s related to quality control like UV-Vis Spectrophotometer, HPLC and GC etc., Chemical/Biochemical and Immunochemical methodologies
Age: 35
Educational Qualification
Essential: M.Sc / M.Pharm.
Specialisation: M.Sc(Lifescience) / M.Pharm
Experience: 1 Yrs
Application end date: 16-09-2015
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Assistant Manager (Regulatory Affairs)
No. of Posts: 1
Category: SC, ST, OBC, GENERAL
Department: Regulatory Affairs
Grade: E0
Scale of pay: 12,600 – 32,500 (Minimum CTC: 5.0 Lacs Appx)
Salary and Other Benefits: In addition to Basic Pay, Annual Increment at 3% of basic pay, Variab
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