Executive QA Job at Aurigene Oncology – Apply Online
Great Place To Work® Certified JUN 2024-JUN 2025 INDIA
WE ARE HIRING
Aurigene Oncology Conquering Cancer
JOIN OUR TEAM
Sr. Executive – Quality Assurance
Location – Bangalore
DESIRED PROFILE:
M.Sc./M.Tech/M.Pharm with prior experience in Quality Assurance with 5 – 10 years’ in GMP pharmaceutical organization.
ROLES & RESPONSIBILITIES
AHU Qualification & Validation
- Develop and execute protocols for DQ, IQ, OQ, and PQ of clean rooms, HVAC, and equipment.
- Review and validate technology transfer documents.
- Review and approve batch manufacturing records.
- Oversee IPQA for dispensing, line clearance, manufacturing, packaging, and dispatch.
- Manage change control and deviations.
- Investigate and implement CAPAS for OOS/OOT events.
- Maintain and update GMP validation procedures.
- Ensure compliance through monitoring and audits.
Analytical Quality Assurance
- Review analytical documents for early-stage development, technology transfer, and pilot production.
- Ensure document quality through collaboration with QC scientists.
- Support regulatory submissions by reviewing development documents.
- Possess hands-on knowledge of analytical method development, validation, and stability studies.
- Investigate and resolve laboratory incidents (OOS/OOT).
- Review data for specifications and test methods.
- Maintain and track departmental documents and reports.
INTERESTED CANDIDATES MAY SHARE THEIR RESUME WITH:
[email protected]
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