[ref. b26832422] Laboratory operations manager [medical device] - Bukit Mertajam

• Reporting to: Quality Director
• Based in Penang
• Attractive remuneration and benefits package

• Champions a culture of patient safety and product quality, ensuring all laboratory operations meet FDA, GMP, ISO, and European regulatory standards.
• Leads the maintenance and ongoing enhancement of the analytical laboratory’s Quality System, driving continuous improvement and regulatory compliance.
• Oversees daily laboratory operations, ensuring efficient scheduling, testing, data review, and timely release of results in alignment with performance objectives.
• Reviews and approves all critical laboratory documentation, including test results, protocols, reports, and SOPs, to ensure accuracy and compliance.
• Manages the transfer of validated analytical methods from donor labs, ensuring smooth integration and adherence to established procedures.
• Selects, qualifies, and oversees external contract laboratories, ensuring all outsourced activities meet internal quality and regulatory expectations.
• Provides expert technical support in resolving method challenges, equipment issues, out-of-specification results, and other analytical troubleshooting needs.
• Drives staff development through performance management, training, and mentorship, fostering a high-performing and compliant laboratory team.
• Leads budgeting, resource planning, and talent acquisition for laboratory operations, while actively contributing to site-level strategic initiatives.
• Ensures robust execution of change control, deviations (NCEP), and CAPA processes, with timely closure, root cause identification, and effective corrective actions.

• Bachelor’s degree in Analytical Chemistry, Chemistry, or Analytical Instrumentation (or equivalent).
• Minimum of 8 years’ experience in pharmaceutical or commercial analytical testing laboratories, including at least 5 years managing chemists or laboratory resources.
• Proficient in analytical method development and validation, with hands-on experience operating instruments such as HPLC, GC-MS, and UV-Vis. Experience working with enterprise laboratory systems (e.g., LIMS, CDS) and within ISO-compliant or regulated environments is highly advantageous.
• Professional certification as a Chemist is preferred.
• skills

• qualifications

• education

Bachelor Degree

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