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Job Description

Cleaning Validation Specialist





YOUR TASK & RESPONSIBILITIES


  • Lead execution of implementation cleaning process and local transport process validations program within GMP areas according to the updated Validation SOP to ensure the cleaning process and local transport process validations had been validated before release to the market/distributor.
  • Lead evaluation activity or investigation of root cause analysis concept for deviation, OOS/OOT, non-conformity or discrepancies in cleaning process and local transport process validation area in Cimanggis Site to determine the root cause and define corrective actions. Check to ensure the timeline of investigation management are meet according to valid SOP.
  • Create or update procedures (e.g. SOPsand templates) related to cleaning process and local transport process validation topic to ensure the procedures are aligned with the updated requirement for the implementation in cleaning process and local transport process area (e.g.:CMS, Bayer Regulation: GOI, GSOP, Supplement, Best Practices, Local regulation such as CPOB, PICs).
  • Lead data compilation of Site Quality Management Reviews related to cleaning process and local transport process validation areas and validation team KPIs, and update status for monthly report, including the ongoing improvement or projects.
  • Lead on monitoring PSS KPI dashboard implementation for cleaning validation team and progress update.
  • Check validation protocols and reports including the related documentations to ensure proper alignment of all documents for the validation activities and to be ready before the execution.
  • Responsible on update tracking and support completion of plans and actions related to deviation control, risk assessment, change management especially for cleaning validation and local transport validation following valid SOP to encourage corrective and preventive actions (CAPA) and follow up the status to closein timely manner.
  • Support to deliver relevant training program (internal and external team) for SOPs including electronic documentation system implementation related to cleaning validation and local transport validation and provide update necessary personnel qualification matrix within team after reviewing by QA Cleaning Validation Spv.
  • Conduct relevant tasks for continues improvement projects related to cleaning process, local transport validation and ensure oversightproper implementation of validated cleaning procedure.
  • Implement appropriate precaution on occupational safety and health including HIRA (Hazard Identification Risk Assessment) of working area as well as security of facilities within Quality Department.
  • Propose to initiate development needs and update the progress through regular one to one discussion (performance-based dialogue).
  • Provide timely and effective feedback, communication or escalation, build trustful and honest working relationship and instill the right first time methodology within the team.

WHO YOU ARE


  • Bachelor’s degree in pharmacy / Apothecary / Chemical Engineering / Industrial Engineering or related area.
  • Relevant experiences: 2-3 years of experience related GMP aspects food supplement or drug manufacturing in Quality or Production function in Pharmaceutical Industry.




Application Period: 30/05/2022 Reference Code: 641301
Division: Consumer Health Location: Indonesia : DKI Jakarta Jakarta : Cibubur Jakarta
Functional Area: Quality Position Grade: R11
Employment Type: Regular Work Time: Flexi Hours (8 working hours)



Contact Us

Address Telephone E-Mail
PT Bayer Indonesia
Menara Astra, 33rd floor
Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia

+622130491111

recruitment.indonesia@bayer.com

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Job Detail

  • Job Id
    7bb7fdf7308c9c5c
  • Location
    id
  • Company
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

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