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QA Operation

Salary undisclosed

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Job Purpose
  • Perform QA Oversight and Product Quality Assurance activity within PT Bayer Indonesia from incoming material in the warehouse until Finish Good dispatching into customer for value stream A/B cluster including issue management, risk assessment handling and batch disposition activity.

Your Tasks And Responsibilities
  • Several pharmacist in this position that already fulfilled qualification act as deputy Responsible Pharmacist for Quality Assurance (QA), responsible for batch disposition activity within Cimanggis site. Assuring that the batches have been produced in compliance with the Marketing authorization and GMP/GDP requirements.
  • Coordinate handling non-conformity management related deviation, complaint, out of specification and defect from supplier including assuring that the investigations according to the timeline are made to determine the root cause and actions are defined.
  • Oversighting in-process control activities during manufacturing process of cluster A/B and non-Operation area to ensure high quality of the product including BAS GMP alarm, evaluation on critical process control monitoring of the product and review Inspection Plan (IP) for IPC activities.
  • Ensure the daily activity to be performed effectively and efficiently accordance with current regulations in Quality (GMP, GDP), Safety, food safety and halal system.
  • Perform activity of QA oversight in the shop floor to ensure the GMP compliance, food safety and halal compliance.
  • Ensure tracking of completion of corrective and mitigation actions related to non- conformity issue in Cimanggis area to maintain the high product quality and manufacturing compliance.
  • Ensure corrective and preventive actions (CAPA) implementation in the shop floor and evaluate their effectiveness to avoid reoccurrence of non-conformity issue.
  • Evaluate reoccurrence, pattern, and trend of non-conformity issue as part of quality management review and develop the mitigation action plan for continuous improvement.
  • Responsible to review the environmental monitoring result and handle environmental monitoring trend report according to valid procedure
  • Provide quality management review report in periodically basis under QA Operation area.
  • Perform activity of batch disposition activity within Cimanggis site. Assuring that the materials received and batches have been produced to be released are in compliance with the Marketing authorization and GMP/GDP requirements.
  • Review, approve and perform activation/ deactivation of the BoM (Bill of Material)
  • Coordinating risk management handling within the site including RA (risk assessment) content review related Quality aspects for non-Operation Area
  • Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within QA Oversight and Product Quality Assurance activities.
  • Coordinating to evaluate HIRA (Hazard Identification Risk Assessment) of working area and ensure the completeness of HIRA training on the team and implementation of HIRA.

Who You Are
  • Pharmacist (for the personnel assigned as deputy of responsible pharmacist for Quality Assurance)
  • 2+ years’ experience in GMP aspects or related area.
  • Deep knowledge on international and local GMP principles for manufacturing of pharmaceutical products, Food supplements and Halal Management.
  • Knowledge on occupational safety, health, and environmental requirements.
  • Understands know how on current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes).
  • Be familiar with GMP Policies and Directives through training to enable controlling implementation into local practices.
  • Having knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements and Halal Management System.
  • Skilled to work and ability to work within teams.
  • Professional English skills.
  • Able to resist any influence, which would hamper management decision making during the absence of QA Operation Lead.

Application Period: September 10, 2024 - September 20, 2024 Reference Code: 828407

Division: Consumer Health Location: Cimanggis - West Java

Functional Area: Quality Position Grade: R09

Employment Type: Contractual Work Time: Flexi Time - 8 Working Hours
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