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Career in QA, QC, Regulatory Affairs and Vaccine department at HLL Lifecare| M.Pharm, M.Sc

 

Clinical courses

HLL Lifecare Limited, a Mini Ratna Central Public Sector Enterprise under the Ministry of Health & Family Welfare, Govt. of India is a global provider of high quality healthcare products & services. With state-of-the-art manufacturing facilities spanning across India, HLL is diversifying into vaccine manufacturing, lifecare services, sanitary napkins besides engaging in procurement consultancy, healthcare infrastructure development and facility management.

Post: Assistant Manager- QA, Deputy Manager-QC, Deputy General Manager - RA, Junior Officer - Viral vaccine

  • Assistant Manager - QA {see below}

ASSISTANT MANAGER (QA VALIDATION)

No.of post: 1

Tasks
- 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 (e.g. autoclave, vial washing m/c, tunnel, lyophilizer, filling m/c, sealing m/c, CIP & SIP unit/s, cold room/s etc..), facility, and utility (e.g. Water & HVAC) 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.

Requirements
Maximum Age: 35 Years as on 01/12/2014.

Scale of Pay: AM: 12600-32500

Pay: Annual CTC AM: 5.50 Lakhs (approx.) at the minimum of the scale.

Qualification:
Essential:
Masters Degree in Pharmacy with atleast 60% Marks. Or Masters Degree in Science (Biochemistry /  Microbiology/ Biotechnology / Molecular Biology) or B. tech (Biotechnology) with at least 60% Marks.

Desirable: Phd

Post Qualification Experience:
Essential: Minimum 1 year  of Experience in Pharmaceutical / biotechnology area in the field of vaccines (bacterial/viral) in lower middle level position.
Should have good communication and interpersonal skills.

Additional Information:
Experience: Minimum 1 year
Qualification:
M.Pharm, M.Sc
Reference Code: HBL/HR/041/2014
Contract Type: Executive - Permanent
Department: QA
Last Date: 24/12/2014

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DEPUTY MANAGER(QC - RM & PM)

No.of post: 1

Tasks
• Manages the RM & PM testing operation, ensuring laboratory processes and provide high quality analytical support for manufacturing, while ensuring compliance of protocols, GMP’s, and safety regulations.
• Ensure the raw materials and packing materials testing (Primary and secondary),Printed packing material (Labels, Cartons and Leaflets etc.).
• Should have extensive experience in vendor qualification and outsource testing
• To lay down specification as per regulatory standards and should have experience in method validations.
• To finalize all equipment specifications and requirements related to RM/PM support for new facilities
• Effective in interdepartmental coordination like warehouse etc.
• Responsible for the compliance of the related regulatory requirements.
• Should have working, calibration& troubleshooting knowledge of all the equipment used in RM & PM Testing.
• To maintain records of all reference standards, retention samples etc..
• Attend the customer, regulatory and internal audits. With the consensus with QA and superiors incorporate the suggestions, changes if any are suggested during such audits.
• Ensure to follow in the department the GMP, Safety and other guidelines applicable.
• To oversee laboratory investigations and reports in response deviations and change control
• Work with direct reports to develop performance objectives and personal development plans and to monitor performance against the objectives.
• Provides leadership, management, and training.
• Review raw data, SOPs, protocols, policies and reports.
• Manage / support special projects as assigned.

Requirements
Requirements
Maximum Age:  35 Years as on 01/12/2014.
Scale of Pay: Deputy Manager (16400-40500)

Pay: Annual CTC - Manager: 6.55 Lakhs  (approx.) at the minimum of the scale.

Qualification:
Essential: Master’s Degree in Science (Chemistry/Biochemistry/ Microbiology/Biotechnology) with at least 60% Marks.

Post Qualification Experience:
Essential:
• Minimum 3years of experience in the field of RM/PM testing with pharmaceutical/ biotech sector and should be in the field of vaccines (bacterial / viral).
• 3 yrs in RM/PM testing and management of team members
• Wide experience in various RM/PM testing aspects in tune to regulatory requirements.
• Experience in preparation of URS, IQ and OQof analytical equipment’s and analytical method validation.

Desirable:
Experience in establishing RM/PM laboratory requirement’s, routine support for manufacturing release and handled new projects

Functional Area: QUALITY CONTROL

Additional Information:
Experience: Minimum 3 year
Qualification:
M.Sc
Reference Code: HBL/HR/021/2014
Contract Type: Executive - Permanent
Department: QC
Last Date: 24/12/2014

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DEPUTY GENERAL MANAGER (RA)

No.of post: 1

Tasks
Dealing with DCGI, WHO, FDA and other regulatory authorities.
Handling regulatory authorities in the regulatory audits, pre-clinical and clinical requirements of vaccine products.

Requirements
Maximum Age:  45 Years as on 01/12/2014.
Scale of Pay: DGM- 29100-54500

Pay: Annual CTC - DGM 11.50 Lakhs  (approx.) at the minimum of the scale.

Qualification:
Essential: Master’s Degree in Science (Microbiology/Biotechnology/ Biochemistry / Molecular Biology/ Pharmacy) or B.Tech in Biotechnology

Post Qualification Experience:
Essential:
Minimum 10 years of experience in handling Regulatory Affairs function of larger corporation out of which minimum 5 years should be in Middle level managerial position.
Experience in handling regulatory affairs matters of vaccines like Measles, Japanese Encephalitis, Pentavalent, Hepatitis B, Haemophius Influenza type B and Rabies.
The candidate should be a dynamic leader with excellent managerial skills with Excellent Communication Skills & Pleasing personality.

Functional Area: Regulatory Affairs

Additional Information:
Experience: Minimum 5 year
Reference Code: HBL/HR/014/2014
Contract Type: Executive - Permanent
Department: Regulatory Affairs
Last Date: 24/12/2014

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Junior Officer (Viral Vaccine)

No.of post: 1

Tasks
• Media, reagent and glassware preparation for cell culture.
• Sterile ultra-filtration
• Environmental monitoring and validation of laboratory equipment.

Requirements
Maximum Age: 40 Years as on 01/12/2014.

Scale of Pay: Junior Officer (Viral Vaccine) (10085-24690)

Pay: Annual CTC - Junior Officer (Viral Vaccine) : 2.50 Lakhs (approx.) at the minimum of the scale.

Qualification:
Essential: Post Graduation degree in life science
Desirable: M.Sc(Microbiology)

Post Qualification Experience:
Essential:
Minimum 3 years of Experience in R&D

Desirable: Experience in biologicals

Functional Area: R&D (Viral Vaccine)

Additional Information:
Experience: Minimum 3 year
Qualification:
M.Sc
Reference Code: HBL/HR/044/2014
Contract Type: Staff/Worker - Permanent
Department: R&D (Viral Vaccine)
Last Date: 24/12/2014

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