Job Description

Major Purpose of the Job: 1. Online review and monitoring of quality control activities and documentation activity. 2. Overall handling and monitoring of all IPQA activities in dispensing, manufacturing and packing area. ? Principal Tasks:- 1. Review of Quality Control, Microbiology related documents & process. 2. Review of GLP/GMP/GDP related activity and documents. 3. Monitoring of sample for QC analysis. 4. Review of finish product analytical data before batch release. 5. Review, logging & closing of OOS and OOT Investigation. 6. Handling of self-inspection documents. 7. Preparation of APR & Online monitoring of trend data. 8. Handling & Monitoring of IPQA Activity in dispensing, manufacturing and packing area. 9. Review of documents/BMR/BPR at each stage of manufacturing and packing. 10. Calibration and validation of IPQA instruments as per schedule. 11. Handling of batch release activity. ? Responsibilities: 1. Review of analytical data and analysis practices. 2. Monitoring of Online Documentation & GLP compliances in Quality control. 3. Review and handling of OOS and OOT.

Skills Required