Description
Co-ordination and communication on routinely basis with US team.
Updation of required status and database for Operations, Packaging, MST/ Technical Services.
To work in collaboration with 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, LOTC, DEHT & CEHT.
Handling of CC, UD, PD, Event and Customer complaints as and when required.
To prepare and review documents for manufacturing activities which includes but not limited to MPR, PBR, MPS, SOP and other manufacturing related documents.
Prepares technical assessment reports and deviations investigations, etc.

Qualifications
B.Sc./ B.Pharm/ M.Sc./ M.Pharm

📌 Senior Executive, Technical Writing Ahmedabad
🏢 Amneal
📍 Ahmedabad