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Sr. Executive

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Pithampur, Madhya Pradesh, India Gufic Group Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities :

Review of all QMS documents related to regulatory submissions

  • Prepare status of all documents related to submission
  • Co-ordinate with all stakeholders of plant for collection of documents
  • Provide all regulatory documents to HO-RA for submission.
  • Evaluation of change control, deviations and out of specifications.
  • Review of specifications, BMRs, BPRs, COA, Method transfer report, Method verification/validation report, Analytical chromatograms, Sterility assurance data package.
  • General Review of plant equipment qualifications, filter validation documents and layouts for its adequacy to support regulatory submission.
  • To facilitate LoA, Debarment certificate, GMP certificate with Internal Teams and for external labs / manufacturing facility in collaboration with vendor qualification and/or supply chain team
  • Support plant team for all regulatory audit
  • Communicate with customer regulatory team for document submission and change control approval.
  • Guide plant team for good documentation practice requirement for submission
  • Respond all queries of customer on time
  • Evaluate all post-approval changes and prepare variation package and share with client
  • Good communication skills and drafting of dossier
  • Well aware about Microsoft (Word, Excel and Power point) skills