Aurigene Oncology HIRING
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 DO, 10, 0Q 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]
