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Alembic Pharmaceuticals
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Executive - DQA

Executive - DQA

Alembic Pharmaceuticals

2 - 5 years

3 - 5 Lacs

Vadodara

Posted:2 months ago| Platform:

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Skills Required

Development Quality Assurance MFR Pdr

Work Mode

Work from Office

Job Type

Full Time

Job Description

KEY RESPONSIBILITIES: Following are the job responsibilities for Development Quality Assurance. Review of analytical documents like Residual solvent statement, Risk assessment for Elemental impurities etc. generated during the product development at Injectable R&D. Review & Approval of Analytical method (including Extractables and Leachables) validation protocols & Reports (Including review of Raw Data). Review of all the protocol based studies related to Extractable and Leachables. Review of Protocol and Report related to Peptide Characterization. Review and approval of R&D specifications, GTPs and other documents. Review and approval of formulation and analytical study protocols and reports. (Equipment Qualification, Submission documents like Justification for specification, Residual Solvent Assessment and Elemental Impurities, Compatibility studies). Review of the logbook and register for completeness and correction as per Good documentation practices and cGMP norms. Review of Filter Validation Study Protocols and Reports. Review & Approval of Master Formula Record (MFR). Review of Product Development Report (PDR). Participation in incidences, investigation & CAPA review and approval. Review method validation protocols and reports for products to be executed at contract manufacturing or research organization. Review & approval of Computer system validation documents as per the defined procedure Review of IT related documents with respect to respective SOP

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Executive - DQA