Raks Pharma Pvt. Ltd. (A division of Amneal Pharmaceuticals)(Dahej)

DEPARTMENT:- Officer to Executive - IPQA (QA | API Manufacturing)
Role Overview: Ensure real-time monitoring and compliance of production activities in API manufacturing with cGMP standards, focusing on consistent product quality, regulatory compliance, and robust documentation.
Key Responsibilities:
- Monitor production activities as per SOPs & GMP.
- Review BMRs, BCRs, and analytical records before API release.
- Provide line clearance at product changeovers and critical process steps.
- Perform sampling of APIs, intermediates, and KSMs with proper documentation.
- Maintain and review retained sample records for intermediates & finished APIs.
- Escalate and support resolution of deviations & discrepancies.
- Support audits (internal & external) with records and compliance data.
Qualifications:
- M.Sc. (Organic Chemistry) / B. Pharma (Preferred).
- 2-8 years of experience in IPQA in an API manufacturing unit.
Skills Required:
- Knowledge of GMP & cGMP compliance.
- In-process QA, documentation review, and data integrity.
- Sampling procedures & record management, Good Documentation Practices (GDP).
- Coordination with QA/QC/Production teams.

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