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Job Description: Quality Assurance Principal Associate
Position Overview
Join our Active Pharmaceutical Ingredient – External Manufacturing (API-EM) team, a dynamic and growing organization that delivers essential medicines to patients worldwide. As a Person in Plant (PIP) API EM Quality Assurance Principal Associate, you will provide critical quality oversight in an external manufacturing environment.
This role is based in Hyderabad, India, with occasional travel to Visakhapatnam (Vizag). Candidates must be within commuting distance.
Key Responsibilities
✅ Serve as the primary quality liaison between Lilly and Contract Manufacturers (CMs).
✅ Provide on-site quality oversight, ensuring compliance with cGMP, regulatory commitments, and Lilly standards.
✅ Review and approve batch records, deviations, change controls, and validation documents.
✅ Support regulatory inspections and participate in Technical Review Boards (TRB).
✅ Disposition API batches and ensure all documentation meets compliance standards.
✅ Collaborate with cross-functional teams, including Joint Process Teams (JPT) and Post Launch Optimization Teams (PLOT).
✅ Drive continuous improvement initiatives to enhance productivity and compliance.
Basic Requirements
✔ Bachelor’s degree in Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
✔ Minimum 5 years of GMP QA experience in API manufacturing.
✔ 10+ years in Quality Assurance within a Big Pharma environment (non-generic products).
✔ Strong knowledge of ICH, EMA, and FDA regulations.
✔ Experience in process validation, technical transfers, and regulatory inspections.
✔ Fluent in English with excellent communication skills.
Preferred Qualifications
🔹 Master’s degree in a relevant scientific discipline.
🔹 Experience in root cause analysis (RCA) and statistical quality control.
🔹 Strong mentoring and leadership abilities.
🔹 Proficiency in computer systems and data integrity principles.
Work Conditions
📍 Hybrid work model (2-3 days onsite per week).
📍 Must be available to support 24/7 manufacturing operations when needed.
📍 Travel requirement (<25%), primarily to Vizag.
How to Apply
