Role & responsibilities

Job Description Deputy Manager IPQA (Sterile Injectables)

Position: Deputy Manager In-Process Quality Assurance (IPQA) – Sterile Injectables

Key Responsibilities

- Ensure implementation of cGMP, GDP, and data integrity practices in sterile injectable manufacturing.
- Perform IPQA activities during aseptic manufacturing, compounding, filling, lyophilization, visual inspection, and packing operations.
- Conduct line clearance, in-process checks, and batch documentation (BMR/BPR) review.
- Review and approve manufacturing activities in compliance with SOPs and regulatory requirements.
- Handle deviations, CAPA, change controls, OOS/OOT investigations, and risk assessments.
- Monitor aseptic practices, personnel gowning qualifications, media fill (APS), and environmental monitoring compliance.
- Support process validation, equipment qualification, cleaning validation, and qualification activities.
- Prepare and review SOPs, protocols, reports, and quality documentation.
- Coordinate and support regulatory inspections (USFDA, MHRA,



EU-GMP, WHO-GMP, PIC/S) and customer audits.
- Lead IPQA team activities, provide training, and ensure effective shop-floor quality oversight.
- Drive continuous quality improvements and ensure audit readiness across manufacturing operations.

Required Skills

- Sterile Injectables Manufacturing
- IPQA / Shop Floor QA
- Aseptic Processing
- Line Clearance & In-Process Checks
- BMR/BPR Review
- GMP, GDP & Data Integrity
- Deviation, CAPA & Change Control
- OOS/OOT Investigation
- Process Validation
- Equipment Qualification
- Cleaning Validation
- Media Fill (APS)
- Environmental Monitoring
- Visual Inspection
- Regulatory Audits (USFDA, MHRA, EU-GMP, WHO-GMP)

Qualification

- B.Pharm / M.Pharm / M.Sc. (Life Sciences or equivalent)

Experience

- 10–15 Years in IPQA for Sterile Injectables, with experience leading teams and handling regulatory audits.

📌 IPQA Deputy Manager - Injectables (Hyderabad)
🏢 Aspiro Pharma
📍 Hyderabad