Sr. Officer-ADL (Documentation)

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Sr. Officer-ADL (Documentation)

work outline icon2 - 4 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

H&H Healthcare And Cosmetics Private Limited

time outline iconIndore, Madhya Pradesh, India

Posted on 01-09-2025

1 Vacancy

Description

  • Prepare, review, and maintain analytical documents including protocols, reports, and SOPs.
  • Compile and verify raw data, results, and observations from analytical studies.
  • Ensure documentation complies with GLP, GMP, and regulatory requirements.
  • Support preparation of dossiers, CTD/eCTD modules, and stability reports for regulatory submissions.
  • Coordinate with ADL laboratory teams for timely collection of analytical data.
  • Review analytical methods, validation documents, and specifications.
  • Handle change control, deviation, and CAPA documentation related to analytical activities.
  • Assist in audit preparations by providing accurate and updated documentation.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

MSc Chemistry

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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