
Quality Assurance Executive To Manager
9 hours ago
Role & responsibilities
- Ensure compliance with cGMP, regulatory, and internal quality standards.
- Manage QMS activities deviations, change controls, CAPA, OOS/OOT, document control, etc.
- Handle Analytical Quality Assurance (AQA) activities data review, audit readiness, and compliance monitoring.
- Oversee In-process Quality Assurance (IPQA) – batch manufacturing records review, shop floor monitoring, line clearance, process compliance.
- Conduct internal audits, support external audits (regulatory and customer), and ensure timely closure of audit observations.
- Drive new initiatives in digitalization, automation, and process improvement in QA systems.
- Training and mentoring of team members to strengthen quality culture.
Preferred candidate profile
- B.Pharm / M.Pharm / M.Sc. (Chemistry) with 4 – 15 years' experience in QA in API Pharma industry.
- Strong knowledge of AQA, QMS, IPQA, documentation, and regulatory compliance.
- Hands-on experience in handling audits (USFDA, EU, WHO, etc.).
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