Supervise, develop, and motivate laboratory analyst to help realize their maximum potential so as to contribute towards achieving the objectives of the department. Provide technical training on laboratory instrumentation to laboratory analysts.
Ensure that all data supporting the resolution of process and method issues have sufficient accuracy to allow for the correct actions to be taken to address the issue. Contribute to the formulation and development of the plans for the implementation of new testing technologies and methods.
Involve in the approving change that may have an impact on product quality, validation and/or cGMP compliance. This may require assessment of testing requirement, co-ordinate testing of samples and comment on change documentation and ensure closure of change. Upon completion, review and ensure closure of changes.
Draft, compile, review and update appropriate laboratory documents such as testing protocol, procedures and guidelines relating to GMP and operational framework of the laboratory.
Lead or participate in investigation arising from laboratory investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations remedial actions for follow-up.
At least a degree in chemistry.
At least 1-4 years experience in an analytical environment, preferably in the pharmaceutical industry
GMP and GLP knowledge
Understanding product specification and method of analysis
Regulatory requirements for method validation
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239