Executive - R&D Quality

5 - 8 years

5 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

 
  • To

    Review and approve of Analytical method validation protocols

    ,

    reports, Analytical method transfer

    protocol/reports, Plant Trouble Shooting Report, Various kind of

    Analytical technical report

    , Justification report, etc.
  • To

    review and approve of QMS documents

    like change control, deviation, Action items, Investigations, CAPA for cGxP compliance and centralised QA oversight for Analytical Development Department and Microbiology.
  • To

    review relevant raw data

    and report for traceability and adequacy to ensure that Method Validation / Method verification/ Method Transfer data verify scientific rigor, adequacy and completeness and to approve relevant reports.
  • To assist in developing procedures / system and for assuring compliance to them by the R&D function by identifying GAP through document review and Audits.
  • To review and approve Extractables and Leachable (E&L) reports.
  • Verify the Product Development Data for the raw data adequacy.
  • To review of Bio Batch/DQ Batch Raw data and release COA in LIMS.
  • To review and approve

    Analytical development and Microbiology Department SOPs.

  • To effective/Obsolete SOPs and related forms of Analytical Development and Microbiology Department in EDMS.
  • Responsible to approve In-vitro bio study and to ensure compliance as per regulatory requirements/ guidance and established procedure.
  • To perform any other activity assigned by reporting manager.

Travel Estimate

Low

Job Requirements

Educational Qualification

M.Sc / M. Pharma

Experience

5-8+ years

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