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Laboratory Operations Manager [Medical device]
RandstadPenangMalaysia, Penang, Malaysia1 hari lalu
Penerangan pekerjaanChampions 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. no additional skills required no additional qualifications required Bachelor Degree
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
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