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Gulbrandsen Technologies
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Research And Development Associate

Research And Development Associate

Gulbrandsen Technologies

4 - 8 years

0 Lacs

gujarat

Posted:5 days ago| Platform: Shine logo

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Skills Required

cgmp process development method development method validation method transfer stability protocol sop ra dq iq oq pq lab validation specification glp compliance internal audits external audits regulatory standards

Work Mode

On-site

Job Type

Full Time

Job Description

As the Head of the DQA department in the Research & Development sector, your role involves leading the team to ensure the implementation of CGMP rules and regulations. Your responsibilities include: - Reviewing the Lab validation Protocol and Report of CRD. - Reviewing the Process Development report for DMF filing. - Reviewing the Specification and STP of Key Raw Material, In-Process, Intermediate stage, and Finished Product. - Reviewing the Method Development Report, Method Validation Protocol/Report, and Method Transfer Protocol of ADL. - Reviewing the stability protocol and Report. - Preparing SOP, Formats / Annexures, Log books, and ensuring RA and GLP Compliance. - Interacting and Communicating with R&D, ARD, QA, and Regulatory Affairs. - Performing internal audits and supporting external audits (FDA, ISO, etc.). - Following the cGMP Rules and regulations with a strong knowledge of regulatory standards. - Being responsible for the preparation, review, and approval of DQ, IQ, OQ, and PQ documents for new equipment or existing equipment. Qualifications required for this role include: - M.Sc. in Chemistry or relevant Science stream. - Minimum 4 years of experience, preferably in Pharmaceutical industries.,

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Research And Development Associate