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