- Preparation, coordination, and successful handling of audits from USFDA, MHRA, WHO-Geneva, and other regulatory authorities.
- Review and compilation of documents required for regulatory inspections.
- Preparation of audit responses, CAPA (Corrective Preventive Actions), and follow-up for closure.
- Ensure plant readiness for regulatory inspections at all times.
- Coordinate with cross-functional departments for audit compliance.
- Document Control Management
- Issuance, revision, control, and archival of all quality documents.
- Preparation and review of SOPs, Specifications, BMR, BPR, Protocols, and Reports.
- Ensure proper documentation practices as per cGMP and Data Integrity guidelines.
- Maintain master documents and controlled copies.
- Deviation Change Control
- Initiate, review, and close deviations in coordination with concerned departments.
- Conduct root cause analysis (RCA) and ensure effective CAPA implementation.
- Handle change control proposals including impact assessment and risk analysis.
- Ensure timely closure of deviations and change controls.
- OOS / OOT Investigation
- Investigation of Out of Specification (OOS) and Out of Trend (OOT) results.
- Review laboratory and manufacturing investigations.
- Ensure compliance with regulatory requirements during investigations.
- Preparation of investigation reports and documentation.
- Qualification Validation
- Preparation and review of qualification protocols (IQ, OQ, PQ).
- Support equipment, utility, and process validation activities.
- Cleaning validation and process validation documentation.
- Coordination with cross-functional teams for execution and reporting.
Required Skills
- Candidate should;have exp. with pharma Formulation/Medical Device industry.
- Positive Communication Skills
- Team Handling
Required Qualification
B.Pharm/M.Pharm
Key Skills
- Ipqa
- Pharma
- Chemist
📌 Executive/Sr. Executive - QA (Dadra and Nagar Haveli and Daman and Diu)
🏢 Quality HR Services
📍 Dadra and Nagar Haveli and Daman and Diu
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