Key Responsibilities
Lead and oversee IPQA activities across sterile injectable manufacturing operations.
Ensure QA oversight of aseptic filling, formulation, sterilization, visual inspection, packing and other manufacturing activities.
Review and monitor BMR/BPR, logbooks, SOPs, protocols and other GMP documentation.
Ensure compliance with cGMP requirements and approved procedures during manufacturing operations.
Provide QA oversight for line clearance, area clearance, equipment status and batch manufacturing activities.
Review and support investigation of deviations, incidents, OOS/OOT, market complaints and CAPA.
Review and approve change controls, SOPs, specifications and manufacturing-related documents.
Ensure effective implementation of environmental monitoring and aseptic practices in coordination with QC.
Provide QA oversight for media fills / Aseptic Process Simulation (APS).
Monitor Positive Documentation Practices (GDP), data integrity and ALCOA+ compliance.
Conduct routine GMP walkthroughs and shop-floor audits and ensure timely closure of observations.
Support batch release activities by ensuring complete and compliant manufacturing documentation.
Coordinate with Production, QC, Engineering, Validation, Warehouse and Regulatory Affairs.




Lead regulatory inspection and customer audit readiness for IPQA-related activities.
Identify GMP gaps and drive appropriate CAPA and continuous improvement initiatives.
Develop, train and mentor the IPQA team and ensure effective manpower deployment.

Key Areas of Expertise
Sterile Injectable / Aseptic Manufacturing
In-Process Quality Assurance
Aseptic Practices &
GMP Compliance
BMR/BPR Review
Line &
Area Clearance
Environmental Monitoring
Media Fill / APS Oversight
Deviation, OOS/OOT &
CAPA
Change Control
Data Integrity &
ALCOA+
Batch Documentation Review
Regulatory &
Customer Audits
Shop-Floor GMP Compliance

Desired Profile
1218 years of experience in IPQA/QA, preferably in a sterile injectable manufacturing facility.
Strong knowledge of USFDA, EU GMP, WHO GMP, Schedule M and ICH requirements.
Proven experience in handling aseptic manufacturing operations and regulatory inspections.
Robust understanding of GMP documentation, investigations, CAPA and change control.
Excellent leadership, team-management and cross-functional coordination skills.
Experience in recent sterile injectable facility commissioning, product launch or technology transfer will be an advantage.

📌 Sr Manager/manager Ipqa Jadcherla
🏢 Aspiro Pharma
📍 Jadcherla