Job Description
Job Description
Key Responsibilities:-
Supervise operations in the filling and filtration sections as per cGMP and SOPs.- Ensure adherence to aseptic behavior, gowning procedures, and cleanroom discipline.- Operate and monitor filling machines, filtration systems, and autoclaves.- Review and ensure correctness of BMRs, logbooks, and documentation.- Support activities including line clearance, equipment preparation, and area readiness.- Collaborate with QA, Engineering, and Support Functions.- Ensure compliance with US FDA, EU GMP, and Annex 1.- Support deviation handling, CAPA, and risk assessments.- Train operators on cGMP, ALCOA, and safe practices.- Maintain oversight of safety, hygiene, and environmental guidelines.
Technical / Functional Skills:- Understanding of cGMP, US FDA, EU GMP.- Knowledge of ALCOA & ALCOA+ principles.- Experience with injectable filling, sterile filtration, autoclave operations.- Knowledge of aseptic practices and documentation.
Behavioral Competencies:- Positive attitude and proactive approach.- Ethical behavior and honesty.- Strong people management.- Good communication and coordination.
InjectablesSpecific Expectations:- Injectable fill-finish experience mandatory.- Exposure to biologic or peptide product filling preferred.- Understanding of sterilization, filtration integrity, and aseptic interventions
Qualifications
Experience: 23 Years
Qualification: B.Pharm / M.Pharm
