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Sr. Executive - QA
Nitika Pharma
Maharashtra, IND
Full-time
Senior · 4+ years experience
Onsite
INR 600000-600000 yearly / year
Discovered 2 weeks ago
Free
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We are looking for an experienced and detail-oriented Senior Executive – Quality Assurance to join our Quality team. The ideal candidate will be responsible for ensuring compliance with cGMP, SOPs, regulatory guidelines, and quality systems across manufacturing and packaging operations. The role requires strong exposure to documentation, audits, investigations, and process compliance.
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Job Summary
We are looking for an experienced and detail-oriented Senior Executive – Quality Assurance to join our Quality team. The ideal candidate will be responsible for ensuring compliance with cGMP, SOPs, regulatory guidelines, and quality systems across manufacturing and packaging operations. The role requires strong exposure to documentation, audits, investigations, and process compliance.
Key Responsibilities
- Ensure implementation and compliance of cGMP, GDP, SOPs, and quality standards in manufacturing and packing areas.
- Review and approve BMR, BPR, logbooks, protocols, reports, and quality documents .
- Handle deviation, change control, CAPA, incident, and market complaint investigations .
- Conduct line clearance, in-process checks, and shop floor QA activities .
- Review and monitor batch release documentation before final disposition.
- Support internal, external, customer, and regulatory audits.
- Prepare and review SOPs, validation protocols, qualification documents, and reports .
- Coordinate with Production, QC, Engineering, and Warehouse teams for quality compliance.
- Ensure timely closure of observations, deviations, and CAPAs.
- Participate in self-inspection and quality risk assessment activities .
- Maintain documentation as per regulatory requirements and data integrity norms .
Required Skills
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