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Jobs or company...

Senior Associate

Salary undisclosed

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JobStreet
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Sr Associate - QCQA Microbiology (Microbiology experience is madatory)

Johor Bahru, Malaysia

Job Responsibilities:

  • SOP preparation for Quality Assurance.
  • Reviewing SOP of other departments especially Quality Control (Analytical and Microbiological) documents (Procedures/ Reports/ Protocols/ Study).
  • Participating Peer Review Meeting for Quality Assurance and Quality Control (Analytical and Microbiological) documents.
  • Coordinating meeting for related cross functional teams related to Peer Review.
  • Review of Change Control pertaining to Quality Assurance and Quality Control (Analytical and Microbiological).
  • Training of cross-functional teams on Quality Assurance procedures.
  • Review CAPA and CAPAEM reports in Trackwise.
  • Familiarisation of Quality Control Analytical function and activities.
  • Document handling for Quality Control Analytical related protocols and reports.
  • Audits:
    1) Internal: Coordinating internal audits, preparing the schedules, and be part of the audit teams.
    2) External: (Partners/ Customers/ Regulatory)
  • Support to provide Quality Control data for regulatory filing as per requirements.
  • Review of Method Validation, Method Verification and Method Transfer protocols and reports.
  • Review and Approval of Batch Release and stability test reports and raw data from Quality Control (Analytical and Microbiological).
  • Review and approval of stability summary reports on Novatek Stability LIMS software.
  • Performing shop-floor inspections including preparation and follow-up of CAPA.
  • Training of Quality Assurance personnel.
  • Ensure adherence of compliance at Quality Assurance area (office and archival area) and to notify any non-conformities.
  • Any other assignment given by reporting manager.
  • Review and Approval of Out of Specification, Out of Trend, and Deviation investigations.
  • Review and approval of Qualification documents physically and associated with eVLMS.
  • Trending and review of QMS wherever applicable.
  • Handling QMS document review for Qualification/Re-Qualification/Calibration, Raw Material/ Packing Material.
  • Microbiology experience is mandatory.
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