Assistant Manager

Role & responsibilities .

• Shop Floor Oversight: Supervise day-to-day IPQA activities in sterile/aseptic manufacturing areas, including dispensing, compounding, vial/ampoule filling, lyophilization, sealing, and visual inspection.
• Line Clearances: Authorize line clearance and area clearance before commencing different operations to ensure zero cross-contamination risks.
• Sterility Assurance & Media Fills: Monitor aseptic practices, cleanroom behavior, personnel gowning qualifications, and actively participate in Aseptic Process Simulations (Media Fills).
• Environmental Monitoring (EM): Review cleanroom environmental monitoring data, viable/non-viable particle counts, and oversight of interventions in Grade A/B zones.
• QMS Investigations: Lead on-floor investigations for deviations, non-conformances, OOS/OOT results, and ensure the implementation of effective CAPA (Corrective and Preventive Actions).
• Document Review & Approval: Review and approve online Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), standard operating procedures (SOPs), protocols, and equipment logbooks.
• Validation & Qualification: Provide QA oversight during process validation, cleaning validation, and qualification of critical sterile machinery (e.g., Autoclaves, Tunnel, Lyophilizers).
• Audit Readiness: Maintain shop floor audit readiness for stringent regulatory inspections ( WHO-GMP) and participate in handling audit queries.
• Team Leadership: Guide, mentor, and train a team of IPQA Executives and Officers, ensuring proper shift allocation and adherence to safety protocols

Preferred candidate profile

• Education: B.Pharm / M.Pharm or M.Sc. in Chemistry/Microbiology from a recognised university.
• Experience: 7 to 12 years of core IPQA experience specifically in a Sterile Injectable / Parenteral facility.