IPC Officer

Bayer
Full Time
Jakarta
Posted 8 hari yang lalu
Job description

IPC Officer





YOUR TASK & RESPONSIBILITIES


  • Provide plan and milestones and execute projects related to continuous improvement within the IPC laboratory
  • To assist IPC supervisor in plan and execute all daily in-process control activity during manufacturing process (Production, Effervescent line, Packing and Inspector, including sampling, testing controlling, data entry, Gemba inspection, calibration instrument regular review on Log sheet, Daily verification balance, sanitation room and GMP alarm report) and report/inform for such any deviation and progress, perform alignment with other department in regards In process control activity relevant.
  • To arrange daily assignment of IPC Personnel and Lead to coordinate and organize a team effectively and efficiently accordance with current regulations in Quality (GMP, GDP) and Safety.
  • Leading investigation and product segregation triggered e.g. by OOS/OOT of either process issue, complaint and deviation etc., with good understanding of working principle on SOP, recording and presenting the investigation summary properly to be shared with respective function.
  • Lead to perform on the job training for new IPC officer/Technical senior officer (Sampling, testing and Reconcile BR)
  • Lead the effective closure of all corrective and preventive actions by performing investigation and recommendation through Deviation Control.
  • Lead and execute tasks within Change Management as a result of process improvement activities, audit finding and general review process.
  • To lead daily tier 1 communication (shift change over) and report regarding Safety, Quality, Delivery (batch record) and others improvement related with IPC.
  • To ensure that the IPC facilities (rooms, Instrument and utensils and other properties) are clean, orderly placed, in its proper validity and good working condition, safety operable and secured, and report to IPC supervisor for any damage/break down/malfunction for further alternative action.
  • To ensure that each of the subordinate is properly trained from cGMP and pharmaceuticals knowledge point of views.
  • To monitor and ensure that all instrument IPC using in operation department are well maintained, qualified and calibrated.
  • Support in the GMP Self Inspection, 5S inspection, HSE inspection & internal/external audit by creating action plan activities, timeline and managing effective closure of all findings relevant to Compliance team.
  • To ensure all sample Composite/Stability/MP/Retained for commercial batch is deliver to QC with timely manner
  • To ensure complete timely Batch Records review, reconcile of batch record and closure to meet site KPI target, including daily BR Scrum Board performance dialogue with key stakeholders. Ensure responsibility and daily target are followed through to ensure sustainability.
  • Perform regular review on Log sheet, Daily verification balance, sanitation room and GMP alarm report.
  • Provide SOPs, GAP review protocols and technical reports. Further, continuously reviews the SOPs used in this field to be up-dated as required to be in line with the up-dated quality guideline and Bayer guideline and monitoring its implementation

WHO YOU ARE


  • Be familiar with Bayer procedures, cGMP, BPOM regulations, occupational health and safety regulations, and management in relation to Operations of PT Bayer Indonesia.
  • Well developed communication and proficiency in both Indonesian and English language (verbal and written).
  • Min have experience in pharmaceutical industries 1 - 2 years/fresh graduate are welcome to apply
  • Preferable as apothecary/pharmacist, and or Bachelor degree chemists, Micro, Biology.v




Application Period: 30/05/2022 Reference Code: 640461
Division: Consumer Health Location: Indonesia : DKI Jakarta Jakarta : Cibubur Jakarta
Functional Area: Production&Manufacturing Position Grade: R09
Employment Type: Temporary Work 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

[email protected]

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