Technical Writing Specialist

5 - 10 years

4 - 8 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  • Updation of required status and database for Operations, Packaging, MST/ Technical Services.
  • Batch record preparation & revision (commercial/site transfer/PV/Scale-up)
  • Regulatory Modules and PDR preparation and review.
  • Periodic Requalification Protocol and Report, PPQP, CPVP, and BHTS
  • Prepare and review Cleaning Validation documents (Matrix, CVP, CVSR & CVRs) in addition to timely monitoring of Annual Cleaning Verification Program, DEHT & CEHT.
  • Management Review Board & Database Management
  • Handling of CC, UD, PD, Event and Customer complaints investigation 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.
  • Ensure training completion as per assigned curriculum.

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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