Posted: 7 months ago
Posted: 7 months ago
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Job Description
- Plan and execute product development activities from concept stage to commercialization as per market and IP requirements.
- Support planning, budgeting, and lifecycle management of FRD projects.
- Ensure all development activities comply with cGMP and GLP guidelines.
- Maintain development documentation including MFR/MFC logs, product codes, and equipment records.
- Coordinate with cross-functional teams (QA, QC, RA, Production, Supply Chain) for smooth project execution.
- Monitor equipment qualification activities (IQ/OQ/PQ/CQ) and maintain SOP compliance.
- Manage procurement of materials required for development trials from warehouse or vendors.
- Review test protocols, reports, batch records, and development documents.
- Participate in investigations related to OOS, OOT, deviations, change control, and root cause analysis.
- Support preparation of Product Development Reports (PDR) and regulatory documentation.
- Monitor scale-up batches, process validation, and commercial validation batches.
- Ensure smooth technology transfer from R&D to manufacturing.
- Coordinate with vendors for outsourced testing and technical activities.
- Support regulatory query responses and audits as a Subject Matter Expert (SME).
- Ensure compliance with health, safety, and environmental standards.
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