Job Responsibility:
• 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
Education: B.Pharma, M.Pharma
Total Experience - 15 - 18 Year in sterile manufacturing plant
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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