QA Executive /QA Officer/ Sr. QA Officer
Location: Dera Bassi, Punjab
Department: Quality Assurance
Industry: Pharmaceutical API Manufacturing
Experience: 3–5 years in API Quality Assurance
Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc.
Key Responsibilities
- Prepare, review, revise and control QA documents as per cGMP and regulatory requirements.
- Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), logbooks and analytical documentation.
- Handle deviations, incidents, CAPA, change controls and root-cause investigations.
- Prepare and revise SOPs, formats, protocols and other quality-system documents.
- Manage document issuance, retrieval, archival, version control and record retention.
- Conduct shop-floor monitoring, line clearance and in-process compliance checks.
- Support equipment qualification, process validation and cleaning-validation activities.
- Review calibration, preventive-maintenance and qualification records.
- Ensure compliance with data-integrity requirements and ALCOA+ principles.
- Participate in internal, customer and regulatory audits and support closure of audit observations.
- Coordinate with Production, QC, Warehouse and Engineering departments on quality-related matters.
- Conduct or coordinate cGMP and SOP training and maintain training records.
- Ensure timely completion and closure of all assigned quality-system activities.
Candidate Profile
- Must have 3–5 years of QA experience in an API manufacturing facility.
- Strong knowledge of cGMP documentation and pharmaceutical quality systems.
- Hands-on experience with deviations, CAPA, change controls, investigations and batch-record review.
- Familiarity with regulatory standards such as WHO-GMP, ICH, USFDA or EU-GMP.
- Valuable documentation, communication and cross-functional coordination skills.
Please share me your updated resume at:
[email protected]
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