Sr. Executive - QA

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.
• Good 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 :-