Quality Control Manager

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Menarini
Bekasi
IDR 100,000,000 - 200,000,000
Be among the first applicants.
4 days ago
Job description

Quality Assurance & Control (Manufacturing, Transport & Logistics)

Full time

  • Minimum education: Registered Pharmacist
  • Have job experience in Pharmaceutical industry as Quality Control Manager at least 5 years
  • Practical experience of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and its application
  • Practical experience of Health & Safety in laboratory
  • Extensive experience with laboratory out of specification (OOE) investigations.
  • Demonstrable leadership, communication skills and managing team
  • Excellent planning, organizational and prioritization skills.
  • Ability to identify skill gaps within team and formulate a training and development plan
  • Application and knowledge of risk management strategies.
  • Ability to develop and maintain effective working relationships with colleagues and other company personnel across a diverse workforce.
  • Ability to work in a team which has both internal and external business reporting relationships

Responsibilities:

  • Review and authorization of finished product, raw material and packing material specifications.
  • Ensure compliance with GMP or alternative local regulations in relevance with the quality of finish products.
  • To regulate and ensure the testing of all samples is conducted in accordance with the procedures or methods that have been validated and approved properly.
  • Ensuring the QC laboratory is fully stocked and equipped to perform the necessary activities.
  • Maintain and monitor project progress related to QC, including managing project budget, resources, risk and issues.
  • Lead Out of Specification (OOS) and Out of Expectation (OOE) investigations by applying initiative and problem-solving skills.
  • Forecasts, prepares and monitors the operating, personnel and capital expenses budgets in Quality Control area.
  • Review, manage and optimize the performance of staff and resources.
  • Tracking of agreed KPI’s, preparation of reports on agreed performance criteria for the QC department, along with the preparation of reports as required to senior management and across site.
  • Adherence of testing schedules as planned in order to meet demand.
  • Ensure maximum co-operation and communication between Quality Control and other departments, to ensure optimum performance levels consistent with the achievement of business plans.
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