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Job in AKUMS Drugs & Pharma | Require Trainee / Assistant Officer / Officer - QC, Manager QA, Research Scientist-AR&D, Executive in DRA, IPR, packaging development

 

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Clinical research courses

AKUMS DRUGS & PHARMACEUTICALS LTD is one of the most innovative, productive and research based pioneer organization of India having its registered office at Delhi and various plants in Haridwar, Uttrakhand giving employment to more than 2000 people. Akums is engaged in the manufacturing of tablets, capsules, injections, syrups on loan licensing and third party manufacturing basis. Akums is having certifications of WHO-GMP, ISO 9001, ISO14001:2004,NDA Uganda, PPB Kenya and complying USFDA , MHRA & other international standards.

Post: Trainee / Assistant Officer / Officer - QC, Manager QA, Research Scientist-AR&D, Executive in DRA, IPR, packaging development

Trainee / Assistant Officer / Officer - QC
M.Sc -Chemistry ./B.Pharm with 0-2 years experience in testing, documentation, validation and method development of pharmaceutical formulations/ injectables/ oral dosage/ ointment & cosmetics etc.
Well versed in handling sophisticated instruments such as HPLC, FTIR, TOC, GC is required. Different positions for different dosage forms.

Manager – Quality Assurance (cosmetics)
M.Pharma /M.Sc./Ph.D/ B. Pharma with 8-12 years experience in testing, documentation, validation and method development of cream, ointment lotion, shampoo in Pharma / Ayurvedic /Cosmetics.
Candidate should have worked with cream, ointment lotion, shampoo in Pharma / Ayurvedic /Cosmetics.
Ability to handle market complaints, change controls, deviations, OOS, Failure Investigation, Art work / correction on drug license etc.
Well exposure in validations, documentations, calibrations, microbiology, Aseptic practices exposure, annual product Review with Trend Analysis.
Yield reconciliation & Line Clearance & In process Quality Assurance checks in manufacturing Sections.
Should be able to work independently & can face national & International audits.
Should be well concern with GMP Rules & Regulations.

Research Scientist-AR&D
Individually handle the projects.
Analysis of Routine and stability samples.
Guide to juniors.
Interpretation of Stability study results.
Troubleshooting
Compilation of results.
Literature search for new projects
Active participation in solving the regulatory queries
Responsible for Analytical method development of various dosage forms, solubility studies, Analytical Method Validation, Analytical Method Transfer etc.
Handling of deficiency letter queried by US FDA.
Preparation & Review of documents like SOPs, STPs for Raw materials, In-process and Finished products, AMVP and AMVR, Analytical method transfer protocols and reports, Study protocols and reports.
Should have thorough knowledge on ICH guidelines, USP, EP & BP.
IQ, OQ, PQ for new instruments
Calibration of Instruments and Equipments and review of reports.
Validation of Excel sheets.
M.Sc in Analytical Chemistry or M.Pharm. in Medicinal Chemistry/ Pharmaceutical Chemistry/ Pharmaceutical Analysis. More than 60% marks in whole career. Chemistry & Mathematics should be compulsory in +2 Science. Post graduation from reputed institute is preferred. For M.Sc. candidates, chemistry should be Hons. in B.Sc.
4 to 6 years of relevant experience in Analytical Research & Development for ANDA projects mostly on US & European markets.
Excellent communication and interpersonal skill.
Proven ability to work creatively and think analytically. Should be fluent in English (written and oral).

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Sr.Officer / Executive - Packaging Development
Packaging Development for different dosage forms and testing and evaluation of packaging material of reference products. Develop packages which do not infringe any patents, are cost effective and novel.
Carry out machine trials with new materials and troubleshoot the problems. Initiate and carry out cost improvement projects.
Change Part Development, Keep abreast with the new technologies in this field.
Sourcing for new or innovative packaging material
Documentation, Issuance of specs., SOPs and STPs, and preparation of Master Packaging Records
Interact with R&D, AR&D, RA, marketing, and corporate medical services for development activity.
Development of primary, secondary, tertiary packing material, Ensure that the new pack is stable at different stages.
Handling of Projects (Cost reduction, standardization, automation etc.)
B.Pharma - Pharmacy, B.Sc - Any Specialization, Diploma - Any Specialization, Other Specialization PG - Any PG Course - Any Specialization, M.Pharma - Pharmacy, M.Sc - Any Specialization,
Experience in Pharmaceutical R&D packaging developmental activities for regulated markets. Should have knowledge of DMF/ANDA requirements.
2 - 5 years of experience in Pharmaceutical R&D packaging developmental activities for regulated markets.
Excellent verbal and written communication skill.
Shall co ordinate independently with internal as well as external customers.

Executive/Sr.Executive-Drug Regulatory Affairs
Preparation of dossier in CTD, eCTD or ACTD formats for different regulated and semi-regulated market.
Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
Ensuring effective and prompt attention and handling of queries from regulatory bodies of various countries.
Implement QA systems and generate SOPs.
Manage and facilitate all registration related activities.
Complete forms and requests originating from government agencies.
Ensuring preparation of documentation according to the requirements of regulatory body of the concerned country.
Negotiating with regulatory authorities & obtain DCGI / local FDA approvals for marketing authorization. Update licensing and collect information on registration instructions and regulations.
Master degree in Pharmacy or equivalents
Extensive knowledge and experiences in the regulatory field. Post graduate in diploma in regulatory affairs will be preferable.
4 - 7 years of experience in Drug Regulatory Affairs. Should have experience and exposure of regulatory submission for USFDA, TGA, MHRA, TPD etc.
Excellent verbal and written communication skill.
Keep up to date with market trends and new developments utilizing information for business improvement,
Careful planning to achieve accurate and timely results.

Sr.Officer/Executive-Intellectual Property Rights
Preparation of Patent landscape and infringement analysis.
Basic knowledge of Patent laws of India, USA and Europe
Making Patent invalidation strategy
Knowledge of Patent drafting and filing procedure
Master degree in pharmacy or equivalents.
Preference will be given to candidate with specialized course in IPR and equivalent
Experience in Intellectual Property Management working for regulated markets, Should have experience on filing solid oral dosage forms for US and EU countries.
3 - 5 years of experience in Intellectual Property Management working for regulated markets
Excellent verbal and written communication skill.
Should have basic knowledge of Patent laws of India, USA and Europe. Should have knowledge of Patent drafting and filing procedure.

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Documentation Officer - AR&D
Preparation of SOPs, STPs, Analytical reports, Analytical validation documents, Calibration records of instruments, product stability reports and other relevant documents.
B.Sc or equivalents.
Experience in documentation of analytical development laboratories
Minimum 2 years of experience in documentation of analytical development laboratories.
Excellent verbal and written communication skill.
Well versed with Windows 98, 2000, XP & Vista, MS Office -2003 & 2007.
Good written & communication skills
Hard working & dedicated

Sr. Research Associate - FR&D
Literature and FOI search for assigned projects
Formulation development of various dosage forms at R&D scale and perform compatibility study, optimization study, stability study etc
Perform the feasibility study, pre-formulation studies. Planning and executing pilot batches, pre-exhibit and exhibit batches as per the requirement of various regulatory market
Preparation of documents like SOPs, Master formula record, tentative specifications for in process and finished products, sampling protocols. Stability protocol and report, Product development report.
Testing of API physical properties, Innovator product characterization
Calibration and maintenance of log books of equipments with ensuring cleanliness of lab and equipments
M. Pharm in Pharmaceutics or equivalent.
2-3 yrs of experiences in formulation development of solid oral dosage forms like tablets, capsules, pellets etc for regulated markets.
Excellent communication and interpersonal skill.
Should have basic knowledge of regulatory requirements for US and EU filing

Research Associate/Senior Research Associate - AR&D
Literature search for assigned projects.
Development of analytical methods.
Analysis of routine and stability samples following GLP and ensuring the accuracy of results.
Procurement of materials.
Preparation of Protocols and Reports.
Calibration of instruments and equipments as per schedule and preparation of report for same.
Execution of Analytical method validation & Analytical method transfer.
Maintaining calibration and qualification records of the equipments and instruments.
Online records in the laboratory note book
Costing of AR&D expenses
Online calculation and keeping raw data in file.
Knowledge on ICH guidelines, USP, EP & BP.
Entry of Instruments & column log books.
M.Sc. in Analytical Chemistry or M.Pharm. in Medicinal Chemistry/ Pharmaceutical Chemistry/ Pharmaceutical Analysis. More than 60% marks in whole career. Chemistry & Mathematics should be compulsory in +2 Science. Post graduation from reputed institute is preferred. For M.Sc. candidates, chemistry should be Hons. in B.Sc.
1 to 4 years of relevant experience in Analytical Research & Development for ANDA projects mostly on US & European markets.
Excellent communication and interpersonal skill.
Proven ability to work creatively and think analytically. Should be fluent in English (written and oral).

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Research Scientist-AR&D
M.Sc in Analytical Chemistry or M.Pharm. in Medicinal Chemistry/ Pharmaceutical Chemistry/ Pharmaceutical Analysis. More than 60% marks in whole career. Chemistry & Mathematics should be compulsory in +2 Science. Post graduation from reputed institute is preferred. For M.Sc. candidates, chemistry should be Hons. in B.Sc.
4 to 6 years of relevant experience in Analytical Research & Development for ANDA projects mostly on US & European markets.
Excellent communication and interpersonal skill.
Proven ability to work creatively and think analytically. Should be fluent in English (written and oral).

FOR ALL POSTS Forward your CV to, resume@akums.in

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LAST DATE: 20th July, 2012

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