Quality Assurance Injectables
4 days ago
Opening for QA executive injectable with 3 years to 8yrs experience in similar job. Candidate should have B-Pharm or M-Pharm degree.
The ideal candidate should have sound knowledge of QMS, Deviation, CAPA, regulatory audits, Validation, APQR, IPQA for injection manufacturing unit. Knowledge of cGMP, documentation practices, and regulatory compliance (ICH, WHO, USFDA, etc.). The role involves reviewing manufacturing and analytical records, ensuring compliance, and supporting internal and external audits.
Job Details
Ensure adherence to cGMP, GLP, and data integrity principles in all QA-related activities.
Manage document control — issuance, review, retrieval, and archiving of controlled documents (SOPs, protocols, logbooks, etc.).
Participate in internal audits, self-inspections, and regulatory audits.
Handle deviations, change controls, CAPA, and incident investigations.
Coordinate with production, QC, and warehouse teams to ensure compliance with company and regulatory standards.
Monitor and review calibration and qualification records of equipment and instruments.
Support vendor qualification, training programs, and quality risk management activities.
Maintain records for product quality reviews (PQRs) and validation documentation.
Assist in ensuring audit readiness and continuous improvement of the quality management system (QMS).
Job Types: Full-time, Permanent
Pay: ₹500, ₹600,000.00 per year
Benefits:
- Health insurance
- Provident Fund
Education:
- Bachelor's (Preferred)
Experience:
- QA injectables: 3 years (Preferred)
Work Location: In person
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