Job ref no.: CT3119337-01#2885

QC Lab Manager, Taiwan

Ethos BC Global

  • Leadership role
  • Responsible for QC Lab
  • Position to be based in Taiwan
Our client is a pharmaceutical company with over 350 different products including generic drugs, branded medicines, biosimilar products, cosmetics and food supplements, for areas including Oncology, Cardiology, Respiratory and Neurology. The company currently has over 2,800 employees in over 35 countries.

 

PURPOSE
The Head of Quality Control Lab is responsible for managing and coordinating the activities of the Quality Control staff engaged in sampling and of testing products, raw materials including excipients and active pharmaceutical ingredients, packaging materials, in process materials, to ensure compliance with quality standards and production schedules.

 

This role covers the Chemistry, Microbiology and Packaging Laboratories.

 

JOB RESPONSIBILITIES
  • Oversee the Laboratory Out of Specification (OOS) and Out of Trend (OOT) test results investigations and ensure thorough root cause analysis and documentation
  • Serve as the technical expert and assist laboratory staff with troubleshooting as well as working actively with Managers and Supervisors for all disciplines in resolving corrective actions and timely completion of reports
  • Participate in process improvements and will assist with the development of laboratory procedures in accordance with current testing guidelines and current GMPs
  • Ensure compliance to stability studies programs
  • Monitor laboratory metric trends on a regular basis and ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists
  • Provide audit support (front room, back room and SME)
  • Lead/sponsor the implementation of improvement initiatives to address recurring laboratory issues
  • Monitor the progress and process for troubleshooting and investigation studies for laboratory issues to ensure appropriate and consistent use of investigative tools and problem-solving techniques
  • Review and approval of Quality Records (e.g. non-conformances, CAPA) related to laboratory events
  • Assess new technology and laboratory automation to increase laboratory efficiency, reduce testing time, reduce data variability, minimize chemical consumption and reduce waste
  • Maintain up to date knowledge of the company’s products and manufacturing processes as well as industry and regulatory trends related to relevant laboratory testing
  • Plan, promote and organize required training activities related to different laboratory testing areas
  • Establish and maintain an annual operational budget
  • Monitor departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices
JOB REQUIREMENTS
  • A minimum of a Bachelor’s degree in Sciences is required. A degree in Chemistry, Microbiology, Pharmacy or Analytical Chemistry highly preferred.
  • A minimum of 7 years working within a GMP highly regulated environment is required.
  • Laboratory experience in a GMP Laboratory environment is required.
  • A minimum of 4 years of supervisory experience is required.
  • Experience with laboratory validations is a must.
  • Ability to define problems, collect data, establish facts and draw valid conclusions.
  • Energetic, with strong interpersonal, organizational and communication skills
  • Ability to perform in a leadership role and to effectively manage people
Please send your updated CV in MS Word format to Anissa Low quoting reference number ANS/AJHK-344573/IA for a confidential review. We regret that only shortlisted candidates will be notified.

 

EA Personnel No R1103376
EBC Connect Pte Ltd
License No 17C8975


ANS/AJHK-344573

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More job information
Job ref no. CT3119337-01#2885
Salary
  • N/A
Job Function
Industry
Experience
  • 7 years
Career Level
  • Middle management level
Education
  • N/A