Lab Controller

JMS Singapore Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

JMS Singapore Pte Ltd is seeking a Quality Assurance Lab Manager to supervise lab operations and ensure strict adherence to EN ISO 13485, cGMPs, and GDPs. You will oversee daily planning, inventory control, and staffing to optimise efficiency while reviewing quality records and implementing corrective actions.

The role requires a Chemistry/Science degree and at least 2 years in QC/QA labs across relevant industries.

Qualifications

• Degree in Chemistry or related discipline.
• Minimum 2 years of technical experience in Quality Control/Assurance lab in medical device, pharmaceutical, food, chemical or process industries.
• Experience supervising a team of laboratory technicians/analysts/chemists/microbiologists is advantageous.
• Knowledge of ISO 13485, USP/EP/JPH will be advantageous.
• Experience operating LIMS is advantageous.
• Willing to travel within the Asia-Pacific region when necessary.

Responsibilities

• Ensure lab operation and practices comply with EN ISO 13485, cGMPs, JQMS and GDPs.
• Supervise daily lab operations: plan work, control inventory, allocate manpower for efficiency.
• Review and approve quality records and documents.
• Plan, coordinate and execute objectives, projects and quality procedures.
• Update QA procedures and specifications; trend for continuous improvement.
• Troubleshoot, analyze quality results and recommend corrective actions.
• Establish and validate new test methods; perform validations.
• Conduct root cause analysis and implement corrective actions with risk-based decisions.
• Monitor equipment calibration and maintenance; ensure proper status.
• Train new technicians and analysts; identify training needs.
• Act as Deputy to management when necessary; perform QA Assistant Controller duties as needed.
• Report quality incidents to QA management and ensure timely closure.

Skills

Quality control

Lab supervision

Documentation

Root cause analysis

Risk-based thinking

Education

Chemistry/Science degree

Tools

LIMS

Job description

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.