We are looking for an IPQA Executive to monitor and ensure in-process quality during manufacturing and packing operations in our API facility. The ideal candidate will be responsible for real-time quality assurance, GMP compliance, and documentation control throughout the production lifecycle.
Key Responsibilities:
- Perform in-process checks during various stages of API manufacturing
- Ensure compliance with cGMP and approved procedures on the shop floor
- Review and verify batch manufacturing records (BMR) and equipment usage logs
- Monitor critical process parameters and sampling activities
- Report and investigate deviations, non-conformances, and OOS/OOT results
- Provide line clearance for manufacturing and cleaning operations
- Coordinate with production and QA teams for quality-related decisions
- Participate in internal audits and continuous improvement initiatives
Key Skills & Knowledge:
- Strong understanding of cGMP and API manufacturing processes
- Positive documentation and observation skills
- Familiarity with QMS tools like deviation, CAPA, and change control
- Ability to work in shifts and on the shop floor
- Knowledge of regulatory guidelines (ICH, WHO, USFDA)