Senior Executive, Technical Writing

1 day ago

Ahmedabad, Gujarat, India Amneal Pharmaceuticals Full time

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.

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