To ensure that all specific process raw materials and packaging materials, factory samples and final products are properly analysed and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.
- Ensures that all specific raw materials / packaging / samples / final products are analysed and tested according to the stipulated quality requirements
- Perform Raw material and packaging material usage decision and Finished Product approval in Laboratory Information Management System.
- Supervise, develop, and motivate the Quality Control Analysts
- Work closely with shared laboratory support to ensure that the lab equipment is available. Liaise with shared laboratory support for vendor support in the event of total equipment breakdown.
- Assist Quality Control Manager in preparing budget for laboratory services and provide support in laboratory resource planning.
- Provide input to Periodic Product Review report and Continuous Process Verification report. Perform Periodic Analytical Laboratory Systems Trend Review.
- Support Site/ Laboratory related investigations.
- Perform gap analysis against Compendium Analytical Procedures and Pharmacopeia.
- Review of the analytical method robustness and make improvement to the analytical methods in consultation with Analytical Development team.
- Minimum Degree in Chemistry or relevant science discipline.
- Senior Chemist will have at least 6 years experience in an analytical environment, preferably in the pharmaceutical industry.
- Self-motivated team player with positive attitude, good communication skills, organisational skills, a continuous improvement mindset and a keen learner
- Problem solving skills (Troubleshooting skills)
- Good knowledge of GMP and GLP, regulatory expectations, ICH and FDA requirements
- Good knowledge on analytical equipment capabilities and operational needs and able to troubleshoot
- Good computer knowledge to support the system/equipment configurations and troubleshooting
- Strong understanding of product specification and method of anlaysis.
- Strong Analytical chemistry background to identify the unknowns.
- Candidates with no prior experience will be considered
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239