Assistant Manager - DQA

5 - 10 years

4 - 8 Lacs

Posted:4 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Should understand and have hands on experience on the preparation and documentation of below subjects required for new and existing products during development, scale up & commercialization:
  1. Literature search report
  2. Feasibility Report
  3. Optimization Report / Lab Validation report/Standard laboratory process etc.
  4. Demo Report / Scale up report etc.
  5. Technology Transfer Document
  6. Trend Analysis in Synthesis and Quality
  7. Analytical Method Development, specs/STP/STDs/INT & validation
  8. Root of synthesis, Process Flow
  9. New ADL methods / Analytical Method Transfer protocol/Stability Studies protocol.
  10. SOP / BMR / BPR
  11. Stability report study

  • Interacting closely with R & D and ADL to develop new documents & train QA & plant on these documents
  • Knowledge of guidelines, SOP, ISO, NABL & related accreditation, cGMP, ICH, OSHAS, MSDS, GMP, GLP, HAZOP, ECOVADIS etc

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