About this role
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
Other facts
About Amneal
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- The Senior Executive is responsible for document management, preparation and review of master documents, and ensuring compliance with UAF in the manufacturing area. Additional responsibilities include handling change control, deviations, and training subordinates.
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