Job Description
- 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.
Qualifications
B.Pharma/M.Pharma/B.Sc./M.Sc.
About Us
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.
