Execute sterile manufacturing , aseptic filtration , filling , sealing , and terminal sterilization activities as per approved batch manufacturing records (BMRs) and SOPs. Ensure strict adherence to aseptic techniques during all operations. Monitor and maintain environmental conditions within controlled areas (Grade A/B/C/D). Supervise line clearance, equipment setup, and area readiness before each batch. Job Types: Full-time, Permanent Benefits: Health insurance Leave encashment Paid sick time Provident Fund Work Location: In person
Execute sterile manufacturing , aseptic filtration , filling , sealing , and terminal sterilization activities as per approved batch manufacturing records (BMRs) and SOPs. Ensure strict adherence to aseptic techniques during all operations. Monitor and maintain environmental conditions within controlled areas (Grade A/B/C/D). Supervise line clearance, equipment setup, and area readiness before each batch. Job Types: Full-time, Permanent Benefits: Health insurance Leave encashment Paid sick time Provident Fund Work Location: In person
Key Responsibilities:1. Raw Material (RM) Testing and Management Perform sampling, testing, and release of raw materials as per approved specifications and SOPs. Review and verify Certificates of Analysis (CoA) and ensure vendor qualification compliance. Maintain traceability and ensure timely availability of RM for production. 2. Finished Product (FP) Testing Conduct physical, chemical, and instrumental analysis of finished products as per validated methods. Ensure all results meet established specifications before batch release. Handle Out of Specification (OOS) and Out of Trend (OOT) investigations in coordination with QA. 3. Stability Studies Execute stability testing as per ICH guidelines and internal protocols. Monitor stability chamber conditions and maintain records. Prepare and review stability reports for product shelf-life determination. 4. Good Laboratory Practice (GLP) Compliance Follow GLP and data integrity principles (ALCOA+). Ensure instruments are qualified, calibrated, and maintained. Maintain accurate and complete documentation of all analytical work. 5. Project Management (PM) Coordinate with cross-functional teams (QA, Production, R&D) for new product introduction and validation activities. Plan and monitor QC deliverables for projects to ensure timely completion. Support analytical method transfer and validation activities. 6. Quality Management System (QMS) Participate in deviation, change control, and CAPA processes. Support internal and external audits (regulatory, client, and corporate). Ensure compliance with all relevant GMP, GLP, and company policies. Assist in preparation and revision of QC-related SOPs, protocols, and records. Job Types: Full-time, Permanent Benefits: Leave encashment Paid sick time Provident Fund Work Location: In person