Job Description
Job Description
Responsible for document management like BMRs, BPRs, master SOPs etc..
Responsible for preparation & review of the master documents of production.
Responsible to ensure UAF working in area.
Responsible for the handling of change control, deviations, investigation & CAPA, etc. Responsible for line clearance activity before commencing the operations.
Responsible to check that all the records and logbooks related to manufacturing, Sterilization, washing and sterilization of equipment's.
Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department.
Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area.
Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area.
Responsible for monitoring all the activities related to General, Control & Aseptic area.
Responsible for Equipment Washing and Autoclave, Dispensing, Filling and Sealing, Garment Washing, Manufacturing, QMS, Vial washing and Tunnel
Skills
Filling, stoppering and sealing, Good Manufacturing Practice (GMP), Regulatory & Compliance Knowledge, People Management & Team Leadership
Qualifications
Officer / Senior Officer / Executive / Senior Executive
