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.

- Strong understanding of GMP documentation, investigations, CAPA and change control.

- Excellent leadership, team-management and cross-functional coordination skills.

- Experience in new sterile injectable facility commissioning, product launch or technology transfer will be an advantage.

📌 Sr. Manager/Manager - IPQA (Jadcherla)
🏢 Aspiro Pharma
📍 Jadcherla