Laboratory Operations Manager [Medical device]

Randstad; Penang; On-site; MYR 120,000 - 180,000; Full time

Job summary

A leading player in the Medical Device Manufacturing Industry is seeking a Laboratory Operations Manager in Penang. This role involves ensuring compliance with FDA and ISO standards, overseeing laboratory operations, and managing team performance. Ideal candidates will have over 8 years of experience in analytical laboratories and a Bachelor's in relevant fields. Attractive remuneration and benefits package are included.

Benefits

Attractive remuneration and benefits package

Qualifications

• 8+ years' experience in pharmaceutical or analytical testing laboratories.
• 5+ years managing chemists or laboratory resources.
• Hands-on experience with laboratory instruments in a regulated environment.

Responsibilities

• Ensure laboratory operations meet FDA, GMP, ISO standards.
• Oversee daily operations, testing, and data review.
• Manage external contract laboratories and ensure compliance.

Skills

Analytical method development

Experience with HPLC

Experience with GC-MS

Experience with UV-Vis

Education

Bachelor's degree in Analytical Chemistry, Chemistry, or Analytical Instrumentation

Job description

We are currently looking for a Laboratory Operations Manager for a leading player in the Medical Device Manufacturing Industry with a legacy of more than 40 years in the world. This position requires your urgent attention.

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

Responsibilities

• 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.

Experience

• 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

• no additional skills required

Qualifications

• no additional qualifications required

Education

• Bachelor Degree