Quality Assurance Executive (Sterile/ Injection/ P

Job Description: • Preparation, execution, compilation & review of Qualification re-qualification protocols. • Handling of master documents & Issuance of controlled documents i.e. Qualification/ re-qualification Documents, Cleaning Validation documents, Hold time study of drug products • Checking & Execution of documents/ activities i.e.,URS, DQ, FAT & SAT, Installation & operational qualification, Performance Qualification/ re-qualification for equipment, utility, Facility etc. • Planning and organizing for cleaning validation/ Hold time study activities of Drug Products: Protocol Preparation, Sampling, coordinating the validation activities, Data compilation • Co-ordination with Production, R&D & Q.C. departments for cleaning validation and hold time study. • Documents review received from Quality Control, R&D and ADL Department. • Protocol/ Report Preparation, Review of Temperature mapping activity. • Review of Re-qualification schedule and monitoring. • Review of Layouts Drawing. • Preparation of SMF & VMP. • Involved and review of Risk analysis. • Co-ordination/ Review of Change controls/ Deviation related activity.