Executive/Sr. Executive - QA
Quality HR Services · Not specified · onsite · Posted 28d ago
Undisclosed7–10 yrsfulltimeSourced from
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About this role
Job Summary
Position: Sr. Executive - QA
Location: 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.
- Candidate should;have exp. with pharma Formulation/Medical Device industry.
- Good Communication Skills
- Team Handling
B.Pharm/M.Pharm
Key Skills - Ipqa
- Pharma
- Chemist
Sourced from naukri
Skills
QAAudit Compliancebprprocess validationcleaning validationCGMPCompilationauditsCAPAChange ControlchemistRoot Cause AnalysisIPQAImpact AssessmentCommunication SkillsManufacturingcomplianceRisk AnalysisPharma
About Quality HR Services
Quality HR Services
Recruitment
30
employees
2017
9 years old
Vapi, Gujarat
India
₹3.1L PA avg
Avg at Quality HR Services
About
Quality HR Services
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10 reviews
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Career growth
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