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Job Description

Validation Manager





YOUR TASK & RESPONSIBILITIES


  • Established and responsible person on Validation Master Plans (sVMP) an OPV master plan related with the manufacturing (production and packaging) process, local transport process and cleaning process validation.
  • Responsible on assuring that manufacturing processes and analytical methods (for that manufacturing process validation) are validated as well as review and approval of validation protocols and reports.
  • As SME to Provide support and expertise on manufacturing process, to other function such as Quality, Production & Packaging Operations, during its product lifecycle. Evaluation and approval of risk assessment and deviations incl. OOS/OOT results related with the validation and on-going process verification (OPV).
  • As SME on statistical data for evaluation to support continues process verification/on going process verification to control the process and define recommendations for manufacturing (production and packaging) validation on any follow up action or improvement.
  • Assuring that in case of discrepancies in validation area, investigations are made to determine the root cause and corrective actions are defined.
  • Ensure CMS implementation, CAPA in validation area (manufacturing process validation, local transport validation and cleaning process validations).
  • Responsible on any validation topic to ensure the procedures are aligned with the updated requirements for the implementation in manufacturing (production and packaging) validation area, including developing ROS (run on standard/Center line on CPP.

WHO YOU ARE


  • Pharmacist with +5 years’ experience in GMP aspects or related area.
  • Deep knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements.
  • Knowledge on occupational safety, health and environmental requirements.
  • Skilled to work within an international team and ability to work within teams.
  • Leadership experience for teams more than 5 peoples.
  • Professional English skills.
  • Able to resist any influence, which would hamper management decision making during the absence of Head of Quality.




Application Period: 15/07/2022 - 22/07/2022 Reference Code: 687641
Division: Consumer Health Location: Indonesia : West Java : Cimanggis
Functional Area: Supply Chain Management Position Grade: VS 1.2
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
    baf9226be7e8ee5e
  • Location
    id
  • Company
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

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