Position Summary

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 provides technical support to the laboratory and other departments. In additional to testing and review the incumbent develops quality procedures, assist in staff development and training as required. The incumbent will also assist in the management and support of key laboratory systems and will also be required to participates in site project teams as necessary.

Core Competencies:

• Good interpersonal skills
• Team player and action oriented
• Good written and oral communication skills
• Good report writing
• Good organizational skills
• Good analytical skills

• Perform analytical and basic microbiological testing accurately and efficiently and in accordance to Standard Operating Procedures (SOPs).
• Perform equipment verification and calibration in accordance to procedures.
• Document all results in accordance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
• Ensure all quality records are attached and/or file as predetermined.
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
• Perform maintenance and troubleshooting of laboratory equipment where required.
• Perform equipment qualification and analytical method validation where required.
• Perform laboratory equipment verification and calibration in accordance to procedures where required.
• Perform basic microbiological testing such as endotoxin level in water and products.
• Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements and that they are filed in accordance to existing policies.
• Participate actively and contribute to site project teams.
• Train fellow colleagues on written procedures and SOPs pertaining to equipment operation, analytical and microbiological test methods and general laboratory operation.
• Perform review and approval of test results in the Laboratory Information Management System (LIMS).
• Perform proactive trending of analytical and microbiological test results.
• Prepare analytical and microbiological for Annual Product Review Reports (APRR).
• 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.
• 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
• Develop and validate test methods as required.
• Lead and manage laboratory equipment validation project independently.
• 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.

• Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology.
• Demonstrated leadership skills.
• Effective problem-solving skills.
• Strong verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team.
• Comprehensive knowledge of cGMPs and appropriate regulations.
• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment.
• Experience in Empower software/ SAP will be an added advantage.

• Experience leading continuous improvement projects.
• Knowledge of lean manufacturing, six sigma methodologies, and statistics.