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.
Positive Communication Skills
Team Handling

Required Qualification: - B.Pharm/M.Pharm

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