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), equipments & 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.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Minimum qualifications: Bachelor’s degree in Computer Science, Mathematics, a related technical field, or equivalent practical experience. 4 years of experience...
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