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Job Description

Validation Specialist





YOUR TASK & RESPONSIBILITIES


  • Create the risk assessment and check for proper alignment of all relevant documents (MBR Pas-X in MES@CIM and MBR in LifeDoc, FORM BOM), for the manufacturing (production and packaging) process validation activities as per established VMP,
  • Perform collection the administrative data for process validation sub-department KPI and initiatives project, also necessary statistical data for evaluation to support process analysis.
  • Create standard procedures (e.g. SOPs and ROS/Centerline parameter) related to manufacturing (production and packaging) process validation topic in accordance with the updated requirements for the implementation in manufacturing (production and packaging) process validation area (e.g.: CMS, Bayer Regulation: GOI, GSOP, Supplement, Best Practices, Local regulation such as CPOB, PICs).
  • Provide information status validation activities to support Validation Master Plans creation and update and support data compilation of Site Quality Management Reviews related to manufacturing (production and packaging) process validation areas.
  • Perform investigation of deviations incl. OOS/OOT results or discrepancies related with the manufacturing (production andpackaging) process validation to determine the root cause and propose corrective actions in the agreed timeline.
  • Follow up the CAPA recommendation from manufacturing (production and packaging) process validation activities/event/deviation/risk assessment in Dev@com System, task of change management system and check to ensure the CAPA recommendation or assigned tasks are closed in timely manner.

WHO YOU ARE


  • Bachelor degree or higher, preferable as apothecary/pharmacist
  • Min. 3-5 years experience in pharmaceutical manufacturing industry
  • Good communication skill Able to work as individual and inteam
  • Good analytical thinking Have experience / knowledge in project management Have knowledge in statistics
  • Having knowledge in GMP principles, regulations, production and packaging process, stability, change management and material / supplier qualification




Application Period: 15/07/2022 - 25/07/2022 Reference Code: 687481
Division: Consumer Health Location: Indonesia : West Java : Cimanggis
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
    b67604cdb9a6cfd4
  • Location
    id
  • Company
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

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