Job Description

The incumbent is member of the Quality Control (QC) Laboratory team. Under the supervision of the QC Laboratory Supervisor, the incumbent will be responsible for performing all analytical testing and the review of the test results generated and the approval of materials. The incumbent shall be able to understand and follow Standard Operating Procedures (SOPs) and assist in trouble shooting laboratory technical issues and stand in for the QC Supervisor in their absence.

POSITION RESPONSIBILITIES

• Assign Standard Work activities by prioritizing according to laboratory demand and available resources when stand in as QC Supervisor.
• Monitor the laboratory status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process when stand in as QC Supervisor.
• Stand in for QC Supervisor when they are absent from work or when they are on project assignments.
• Provide advice, guidance, support and training to team members in order to improve the teams' capability.
• Develop working process to enhance GMP standards for the team.
• Develop On Job Training (OJT), Job Safety Assessments (JSAs) and Risk Assessments (RAs) for laboratory operations.
• Conduct OJT training for new hires.
• Troubleshoot all operating deviations and issues and coordinate with other function when required.
• Perform chemical analysis using wet chemistry methods and analytical instrumentation, including HPLC, GC, particle size analyzer etc.
• Ensure that tests assigned are performed in a timely manner in accordance with validated test protocols and procedures.
• Perform instrument calibration, maintenance and troubleshooting. Able to prioritize based on operation needs.
• Support laboratory operations, including sample receipt, sample subdivision and labeling, waste disposal, stability sample packing.
• Advise on the significance of test results and follow up with appropriate course of actions.
• Actively participate in Safety initiatives, typically a role model for other analyst. Ability to perform investigation related to EHS.
• Participate in 5S team initiatives and practice good housekeeping.
• Coordinate work flow and laboratory activities according to QC sample and testing plans.
• Lead and conduct laboratory investigations/incidents such as out of specification investigation and equipment troubleshooting investigations, identify root causes and implement appropriate corrective action and preventive measures.
• Participate in Analytical Method Transfer Exercise and independently resolve issues associated with test methods
• Review test reports and ensure that all laboratory documents are in a constant state of regulatory compliance and inspection readiness.
• Develop test methods or instrument Standard Operating Procedures (SOPs), write and update Quality Procedures.
• Plan and deliver technical training to colleagues. Developed and review training materials as required e.g. Basic lab techniques.
• Close coordination with cross function colleagues / Vendors to achieve desire outcome ( e.g. Lab equipment installation/ Validation/ Service contract / External contract lab testing fulfillment).
• Commitment to work and positive influencer/role model/motivate others for overall operational excellence.

EDUCATION

• Diploma in Science (preferably Chemical Process Technology) or equivalent.

EXPERIENCE

• Minimum 5 years of quality control experience in the pharmaceutical industry.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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