Manager -2

Job Description

Position: Sterile Manufacturing Supervisor

Department: Penem Production

Designation: Manager - II

Total Years of Experience: 10+ Years

Education Qualification: B. Pharma / M. Pharma

Job Role: Critical & control area supervision, QMS activities, Water System.

Job Responsibilities:

• To ensure contamination control are available and followed at site as per Contamination Control Strategy (CCS) and respective procedures.
• To plan the activities of the department as per weekly / monthly delivery schedule.
• To check and verify the transfer of raw material from R. M. staging to process area.
• Issuance of raw material and packaging material from block store to process area as per P. O. and updates the stocks in SAP.
• To ensure online recording data.
• To complete the documentation of the critical, controlled area, garment area and Water system on time.
• To meet the production schedule both in quantity & quality.
• To manufacture and fill the sterile dry powder injectable batches as per production plan.
• To ensure completion of training for workman and self within defined time.
• To follow & implement the current Good Manufacturing Practices, EHS practices and SOP during work.
• To ensure completion of SAP Transaction on time.
• To ensure timely completion of validation/qualification activities for aseptic process simulation (Media Fill), equipment s & systems as per approved procedure.
• To review the Batch Production Record.
• To ensure the effective control on usage of men, machine, & material in the department.
• To organise & implement the on-job training activities in the department & ensure training of all team members of the department.
• To ensure the hygiene & maintenance of department, system & equipment are in neat & tidy condition at all time.
• To review & initiate the CAPA, Deviation & Change control as required.
• To ensure the required initial & continuous training is being carrying out for all the employees.
• To implement the recommendation of internal/external audits outcome.
• Handling of QMS activities (OOT/OOS/Market complaint/Investigation).
• Any other responsibility / Work activity that may be assigned from time to time.
• To maintain Harmony relationship with peers, seniors at work place and ensure the win - win situation for resolution of issues.