Quality Control Manager

About the role

Lead and manage QC routine operations covering SCQC, Chemical and Microbiology Laboratories. Ensure compliance with GMP, ISO standards, data integrity and laboratory requirements while driving operational efficiency, technical excellence and continuous improvement.

Key responsibilities

• Lead and oversee daily QC laboratory operations to ensure smooth, efficient and compliant activities
• Ensure compliance with GMP, GLP, MS ISO/IEC 17025, ISO 9001, ISO 13485 and other applicable standards
• Act as Quality Management Representative for MS ISO/IEC 17025 and support internal and external audits
• Ensure audit findings, deviations, non-conformances and investigations are properly addressed and closed on time
• Uphold ALCOA, data integrity and good governance practices across QC operations
• Review and approve QC documents, test results, specifications, methods, validation/verification protocols and reports
• Ensure laboratory equipment, calibration, qualification, maintenance and inventory are properly managed
• Lead root cause analysis, risk assessments and scientifically sound problem-solving initiatives
• Develop technical competencies and training plans for QC laboratory personnel
• Drive laboratory improvement, LEAN initiatives and implementation of efficient analytical methods

About you

• Bachelor's Degree in Science or related discipline
• Minimum 8 years of relevant experience in analytical laboratory operations, preferably within pharmaceutical manufacturing or testing
• Experience in QC laboratory management, GMP and ISO 17025 requirements
• Strong leadership, analytical, problem-solving and technical skills
• Good knowledge of laboratory systems, testing methods, quality management and regulatory requirements
• Experience in audit management, investigations, risk assessment and continuous improvement
• Membership with Malaysian Institute of Chemistry (IKM) or equivalent is an advantage