About this role
Responsible for document management like BMRs, BPRs, master SOPs 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 for line clearance activity before commencing the operations.
Responsible to check that all the records and logbooks related to manufacturing, Sterilization, washing and sterilization of equipment’s.
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. Aseptic vial/bag filling , Responsible for vial washing , autoclave and terminal sterilization operation.
Skills:
Complying with Good Manufacturing Practices (GMP) and regulatory standards (USFDA, MHRA, WHO, etc.).
Completing Batch Packing Records (BPRs), logbooks, and deviation reports.
Maintaining traceability and following SOPs strictly
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-Manufacturing is responsible for document management, preparation and review of master documents, and ensuring compliance with UAF in the area. Additionally, the role involves handling change control, deviations, investigations, and CAPA, as well as monitoring activities related to manufacturing and sterilization.
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