Lab Controller

Job Responsibilities:

• Ensure the Lab's operation and practices are following to EN ISO 13485, current Good Manufacturing Practices (cGMPs), JQMS and Good Documentation Practices (GDPs).

• Supervise and control the daily operation in lab by planning of work, inventory control and manpower arrangement for optimisation of efficiency.

• Review and approve quality records and other documents.

• Plan, co-ordinate and execute objectives, projects and quality procedures.

• Plan, review and update QA procedures and specifications.

• Troubleshoot and recommend corrective actions by analysing quality results and make sound judgement.

• Perform new test method establishment and relevant test method validations.

• Perform root cause analysis and implement appropriate corrective action during failure investigation. This is to be followed by ensuring all actions are completed. Make decisions based on scientific and logical rationale with a risk-based approach.

• Review regularly for continuous improvement and safety-related initiatives.

• Ensure the maintenance and calibration status of the test and measuring equipment is in proper

• Trainer to new technician / analyst / Assistant Controller / Controller / Senior Controller.

• Identify training needs and recommend relevant training for staff.

• Deputy to Assistant Manager / Manager / Senior Manager if they are not available.

• Perform QA Assistant Controller related jobs if deemed necessary or as instructed by QA assistant manager and above.

• Perform other QA related jobs as instructed by QA assistant manager and above.

• Report to QA assistant manager and above for any quality related incident or any incident that may have impact on quality.

Job Requirements:

• Degree in Chemistry / Science or in a related discipline.

• Minimum 2 years of technical experience in Quality Control / Assurance laboratory within the medical device, pharmaceutical, food, chemical or process industries.

• Experience in managing/supervising a team of laboratory Technician, Analyst, Chemist and Microbiologist will be advantage.

• Knowledge in ISO 13485 / Unted State Pharmacopoeia / European Pharmacopoeia / Japan Pharmacopoeia will be advantage.

• Experience in operating LIMS (Lab information Management System) will be advantage.

• Willing to travel within the Asia-Pacific region when necessary.