Jobs / Singapore / Glaxosmithkline LLC
Analytical Chemist (1-Year Contract)
Glaxosmithkline LLC · 🌍 Singapore - Jurong
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Sponsor Radar — Glaxosmithkline LLC
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About the role
To assist the Laboratory Operations Manager to manage the infrastructure and support aspects of the Laboratory to ensure that the systems in place are compliant with defined quality requirements. To ensure that all value stream specific process raw materials, non-routine samples, envops, intermediates and final products are analysed and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards. To ensure that all investigational samples or evaluation samples are analysed and results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards. To ensure all new methods and specifications introduced as part of new product introduction or product lifecycle are validated or verified in compliance with defined quality standards and regulatory requirements. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Collaborate with laboratory analyst 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. • 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. • Assist Laboratory Operation Manager in supporting laboratory budget management and Analytical Laboratory resource planning. • 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. • Assumes the role of corporate ERP system BPE when required • Ensure regulatory compliance, perform GSK Management Monitoring audit and support Independent Business Monitoring (IBM) and external audits • Ensure timeliness and accuracy of Pharmacopoeia & ATS review • Ensures that all value stream specific raw materials / non-routine samples / envops / intermediates and final products are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. • Provide input to Value Stream Periodic Product Review report. • Constantly monitor product quality and highlight the anomalies to the manufacturing group and higher management Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: • Analytical Chemist / Analytical Development Chemist: At least a degree in chemistry and minimum 1-4 years’ experience in an analytical environment, preferably in the pharmaceutical industry. • Senior Analytical Chemist / Analytical Development Chemist: At least a degree in chemistry and minimum 4-6 years’ experience