Aurigene Oncology, a Great Place To Work Certified™ (June 2024-June 2025), is a leading biopharmaceutical company dedicated to conquering cancer through innovative research and development. With a strong commitment to diversity and equal opportunities, Aurigene fosters a dynamic work environment for professionals in the pharmaceutical and biotechnology sectors.
Job Title: Deputy Manager – Development Quality Assurance (API-QA)
Location: Bangalore, India
Experience: 10-14 years
Qualification: Master’s degree in Pharmaceutical Chemistry / Organic Chemistry / Quality Assurance
Job Description & Responsibilities
As a Deputy Manager – Development Quality Assurance (API-QA), you will play a crucial role in ensuring compliance and quality standards in API (Active Pharmaceutical Ingredient) development. Key responsibilities include:
- Preparation and Review of SOPs & Guidelines: Develop and review Standard Operating Procedures (SOPs) and guidelines for Development Quality Assurance (DQA).
- Documentation Review: Evaluate protocols, test methods, Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), ROAS, COAs, and other critical documents in collaboration with PRD, ARD, and QC teams.
- Process Development Review: Assess KSM/KRM identification, specification proposals, analytical method validation reports, stability protocols, and safety studies.
- Quality Investigations: Lead investigations into laboratory incidents, OOS (Out of Specification), OOT (Out of Trend), ensuring root cause analysis (RCA) and CAPA (Corrective and Preventive Action) implementation.
- Change Control & Deviation Management: Review and approve Change Control Requests (CCRs) and Deviations, assessing their impact on quality.
- Audit Management: Conduct internal and external audits, track Quality Metrics, and ensure CAPA effectiveness for continual improvement.
- Stability Management: Oversee stability protocols, data review, and stability summary reports for drug substances and drug products.
Desired Skills & Competencies
- Strong expertise in API Quality Assurance within a pharmaceutical R&D environment.
- In-depth knowledge of GMP, GLP, ICH guidelines, and regulatory compliance.
- Proficiency in quality risk management, deviation handling, and audit processes.
- Excellent analytical, problem-solving, and documentation skills.
Why Join Aurigene Oncology?
- Great Place To Work Certified™ organization.
- Opportunity to work in a cutting-edge oncology research environment.
- Commitment to employee growth, diversity, and inclusion.
How to Apply?
Interested candidates can send their updated resume to:
📧 gayathiri_n@aurigene.com
