To assist the Analytical Tech Transfer Manager ensure that testing activities or methods and specifications introduced or changed as part of product lifecycle are validated or verified in compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards. To support all analytical testing activities required for the resolution of process and method problems / issues method validation and the introduction of new measurement technologies and analytical tests.
Supervise develop and motivate laboratory analyst to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
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/or methods.
Ensure a safe working environment for the laboratory through participating or issuing safety risk assessment for product specific methods or techniques or material and performing 6S inspection.
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
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.
Open to fresh graduates with a minimum degree in chemistry or related field
Minimum 1-4 years experience in an analytical environment preferably in the pharmaceutical industry.
Good knowledge of GMP
Understanding product specification and method analysis
Knowledge of laboratory instrumentation
Laboratory support procedures
Regulatory requirements for method validation
Good communication skills
Problem solving skills
Project management skills
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Required Experience:
IC
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