We Emcure Pharmaceuticals Limited hiring Officer - QA (R&D)/ QA Analytical R&D, Location of the job will be Pune, Maharashtra, Minimum experience required to perform this job will be 2 to 5 years, interested can share cv @ manojt.kumar@emcure.co.in
Job Description:
- Revision in Method of analysis (MOA) and specification due to Pharmacopoeia updates requiring method development/method changes, if any.
- Receipt of Technical Report, Interoffice note, SOPs, Drug substance specification, Drug product specification, Raw material specification, In-process specification and Method of Analysis.
- Initiation and Handling of change controls related to preparation/revision in the specification, Method of Analysis, Standard test procedure, Standard operating procedure and related documents.
- Update, revision and loading of specification in SAP system.
- Review of SAP generated specification.
- Preparation/revision and review of Drug substance specification, Drug product specification, Raw material specification, In-process specification, Method of Analysis, Standard test procedure and Standard operating procedure as per the requirement.
- Initiation of change control for the change in SAP specification.
- Concurrence/ review of change implementation of change control forms as a designee of Department Head/Site QA.
- Issuance of documents to relevant sites (i.e. Specifications, MOAs, STP and SOPs).
- Initiation and review of Deviation, Discrepancy and Risk assessment reports.
- To ensure compliance with Ethical conduct and data integrity policy.
- Perform additional tasks as assigned by the Team Leader and Head of the department to enhance quality system management, cGMP & compliance.
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