Manager Quality Assurance

Roles & Responsibilities
• Lead and manage Quality Assurance teams with multiple direct and indirect reports
• Oversee Quality Management System (QMS) activities including OOS, Change Control, Deviations, and CAPA
• Lead and review investigations related to OOS and deviations, ensuring scientifically sound root cause analysis and effective CAPAs
• Review analytical data including chromatography and non-chromatography results to ensure compliance and data integrity
• Support batch release activities using LIMS and SAP systems
• Handle and support internal, external, and regulatory audits related to QC and AQA functions
• Ensure compliance with GMP, SOPs, and regulatory requirements across quality operations
• Collaborate with QC, Manufacturing, and other cross-functional teams to maintain product quality and inspection readiness
• Drive continuous improvement initiatives within quality systems and processes

Qualification
• M.Sc in Biotechnology or Biochemistry
• M.Pharm

Experience
• 12–15 years of experience in Quality Assurance within pharmaceutical or biotechnology organizations

Skills
• Strong expertise in QMS (OOS, Deviations, Change Control, CAPA)
• Proven experience in investigation writing and review
• Analytical data review skills (chromatography and non-chromatography)
• Hands-on experience with LIMS, SAP, and electronic QMS platforms
• Audit handling experience in QC and AQA environments
• Batch release experience using LIMS and SAP
• Leadership and team management capabilities
• Candidates with exposure to both QC & AQA and biotechnology companies preferred

About the Organization
Lupin is a global pharmaceutical and biotechnology company focused on innovation, quality, and regulatory excellence. The organization is committed to delivering high-quality medicines while fostering strong quality systems and continuous improvement across its operations.