Job Description:

Position: Sr. Executive - QA

Location: Bhimpore - Daman

Experience: 7 - 10 Years

Industries: Medical Device

Responsibilities:

- 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.
- Valuable Communication Skills
- Team Handling

Required Qualification: - B.Pharm/M.Pharm

Salary :- Upto 8.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-

📌 Executive/Sr. Executive - QA (Diu)
🏢 Quality HR India
📍 Diu