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)
🏢 Recognized
📍 Ahmedabad