About this role
- To work in collaboration with US team members to create the highest quality documents and timely delivery of outputs consistently.
- Prepare and review PPQP, PPQR, PSP, PSR, CPVP, BBHS, regulatory modules (for submission/validation batches).
- Prepare and review Cleaning Validation documents (Matrix, CVP, CVSR & CVR’s) in addition to timely monitoring of Annual Cleaning Verification Program, DEHT & CEHT.
- Handling of CC, UD, PD, Event and Customer complaints as and when required.
- To prepare and review documents for manufacturing and packaging activities which includes but not limited to MPR, PBR, MPS, SOP and other manufacturing and packaging related documents.
- Prepares technical assessment reports and deviations investigations, etc.
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Other facts
About Amneal India
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 role involves collaborating with US team members to create high-quality documents and ensure timely delivery. Responsibilities include preparing and reviewing various regulatory and manufacturing documents.
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