Production FP Manager

Department Drug product Manufacturing/ Fill finish Qualification B. Pharm / M. Pharm Experience 12-15 years Designation Manager/ Sr. Manager No. of positions 01 Job Description Experience in Fill finish activities with knowledge in handling the vials filling operations/ Exposure in documentation/ QMS activities for biological products. Candidate should have hands on experience of handling and Operation of equipment’s in aseptic fill Finished area e.g. Autoclave, Vial washing machine, Sterilizing and depyrogenation tunnel, Filling machine, Cap sealing machine & Lyophilizer. Candidate should have through knowledge and participated in media filling activities in regular basis. Documentation Candidate should have sound knowledge on Preparation of SOPs, BMR, PV, CV & media fill protocols and qualification documents for new equipment i.e. IQ, OQ, PQ To participate in re-qualification of equipment and aseptic area as per schedule. Quality aspect To prepare and execute QMS activities i.e. Change control, deviation, risk assessment, scale-up protocol, incidents, CAPA and investigation for aseptic area. To involve and ensure the internal and external audit compliance actvities Show more Show less