Quality Control Manager (Pharmacist)

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

Quality Assurance & Control (Manufacturing, Transport & Logistics)

Full time

  • Minimum education: Registered Pharmacist
  • Experience: At least 5 years as Quality Control Manager in the Pharmaceutical industry
  • 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 and communication skills, and managing a team
  • Excellent planning, organizational, and prioritization skills
  • Ability to identify skill gaps within the 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 with 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 relevant to the quality of finished products
  • Regulate and ensure the testing of all samples is conducted in accordance with validated and approved procedures or methods
  • Ensure the QC laboratory is fully stocked and equipped to perform necessary activities
  • Maintain and monitor project progress related to QC, including managing project budget, resources, risks, and issues
  • Lead Out of Specification (OOS) and Out of Expectation (OOE) investigations by applying initiative and problem-solving skills
  • Forecast, prepare, and monitor the operating, personnel, and capital expenses budgets in the Quality Control area
  • Review, manage, and optimize the performance of staff and resources
  • Track agreed KPIs and prepare reports on agreed performance criteria for the QC department, along with reports required for senior management and across the site
  • Adhere to testing schedules as planned to meet demand
  • Ensure maximum cooperation and communication between Quality Control and other departments to ensure optimum performance levels consistent with the achievement of business plans
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