Job Description

Key Responsibilities:

Responsible for document management like BMR's, BPR's, master SOP's 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 to give training to all the subordinates, technicians and operators of the department. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD's instruction and guidance. Responsible for line clearance activity before commencing the operations. Responsible to check that all the records and logbooks related to aseptic manufacturing, vial filling and vial sealing machine. 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 to ensure qualification and calibration status of equipment and instruments to avoid due/overdue. Responsible to ensure scheduled activity of respective area/equipment/instruments. Responsible to attend training as per schedule and to ensure training and work as per TNI. Follow the cGMP, Good Document Practice and discipline in the Company Premises.

Skills:

Filling, stoppering and sealing | Expert Equipment Operation & Cleaning (CIP/SIP) | Proficient Dispensing | Proficient Sterilization through Autoclave | Proficient Mixing | Proficient Decartoning | Expert Washing | Proficient Terminal Sterilization | Proficient Good Manufacturing Practice (GMP) | Proficient Batch Documentation and Record Review | Proficient Cleaning & Line Clearance | Beginner People Management & Team Leadership | Beginner

Qualification: M.Pharm./ B.Pharm./ M.Sc.


Exp.: 3-7 years


Candidate shall have experience in the Manufacturing of Injectable Products