Quality Control Analytical Manager (Malaysia)

I'm currently assisting a client in search for a Senior Quality Control Laboratory Manager. This pivotal role involves overseeing the Quality Control (QC) laboratory operations, ensuring compliance with regulatory standards, and leading initiatives to maintain and enhance quality systems.

Key Responsibilities:

• Leadership & Compliance:
  
  • Ensure implementation and adherence to cGMP systems and procedures within the QC department.
  • Monitor and oversee quality-related activities to ensure timely completion of key deliverables.
  • Ensure all laboratory activities comply with established procedures and promptly address any non-compliance issues.
• Resource & Operational Management:
  
  • Plan and allocate resources, including manpower, instruments, and equipment, based on workload to ensure smooth functioning of routine activities.
  • Manage capital expenditure requirements based on manufacturing planning and prepare laboratory budgets accordingly.
  • Ensure effective planning and utilization of resources to support uninterrupted manufacturing operations.
• Quality Systems & Documentation:
  
  • Monitor the Quality Management System (QMS) for the QC department, including oversight of OOS, CAPA, Change Management, and Deviations.
  • Review audit reports and manage Corrective and Preventive Actions (CAPA) responses from the QC department.
  • Respond to Quality Assurance (QA) for audit compliance reports by consolidating action items from the QC team.
  • Review and resolve customer and regulatory complaints, and oversee the review of Quality Agreements.
• Stakeholder Engagement:
  
  • Interact with internal and external stakeholders to address quality-related queries and facilitate method and technology transfers.
  • Collaborate with corporate quality systems to ensure harmonization with corporate quality philosophies.
  • Participate in cross-functional teams and contribute to key decision-making processes.
• Continuous Improvement & Training:
  
  • Conduct periodic assessments of procedures and processes in coordination with cross-functional teams to ensure quality assurance.
  • Stay abreast of industry developments to implement improvements in quality systems.
  • Oversee recruitment and performance assessments of QC personnel in line with the organization's Performance Management System.
• Authority & Approvals:
  
  • Authorized to approve relevant documents on behalf of the Head of Department (HOD).

Requirement:

• Bachelor's degree in a relevant scientific discipline
• Minimum of 10 years of experience in a quality control laboratory setting, with prior experience in a managerial role.
• Strong knowledge of cGMP regulations and quality management systems.
• Proven ability to lead cross-functional teams and manage complex projects.
• Excellent communication, analytical, and problem-solving skills.

Registration Number: R24123122

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