Job Responsibility
JOB DESCRIPTION
- Responsible to update on self-hygiene.
- Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department.
- Responsible for preparation & review of the master documents of production.
- Responsible for preparation and review of protocols and reports based on the requirements.
- Responsible for document management like BMR's, BPR's, master SOP's etc.
- Responsible for the handling of change control, deviations, CAPA, investigation etc.
- Responsible for operations like manufacturing, filling & sealing, labeling and packing operations.
- Responsible for preparation of production planning on monthly and also daily as per the requirement and availability of materials.
- Responsible to prepare daily production report as per the production achieved.
- Responsible to ensure that all equipment and lines are in validated and calibrated status.
- Responsible to follow cGMP, GDP and discipline in the department and to ensure that all employees follow the same.
- Responsible to check that all the records and log books related to manufacturing, washing, filling, sealing and sterilization of equipment.
- 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 to attend the training as per training schedule and to ensure training as per TNI.
- Responsible to maintain the facility in compliance manner and keep the area ready of inspection.
Skills
Filling, stoppering and sealing | Beginner
Equipment Operation & Cleaning (CIP/SIP) | Proficient
Dispensing | Proficient
Sterilization & Depyrogenation | Proficient
Mixing | Beginner
Decartoning | Beginner
Washing | Beginner
Filtration | Proficient
Process Validation | Proficient
Troubleshooting (Problem Solving) | Proficient
Packing Process Understanding | Beginner
People Management & Team Leadership | Beginner
Qualifications
Education: B.Pharma, M.Pharma
Total Experience - 15 - 18 Year in sterile manufacturing plant
