Analytical Chemist (One Year Contract)

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, envoys, intermediates and final products are analyzed 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 analyzed 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:

1. Supervise, develop, and motivate laboratory analysts to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
2. Provide technical training on laboratory instrumentation to laboratory analysts.
3. 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.
4. Contribute to the formulation and development of the plans for the implementation of new testing technologies and methods.
5. Ensure a safe working environment for the laboratory through participating or issuing safety risk assessment for product specific methods, techniques or materials and performing 6S inspection.
6. Assist Laboratory Operation Manager in supporting laboratory budget management and Analytical Laboratory resource planning.
7. Involve in the approving change that may have an impact on product quality, validation and/or cGMP compliance. This may require assessment of testing requirements, coordinate testing of samples and comment on change documentation and ensure closure of change.
8. Upon completion, review and ensure closure of changes.
9. Draft, compile, review and update appropriate laboratory documents such as testing protocols, procedures and guidelines relating to GMP and operational framework of the laboratory.
10. Lead or participate in investigation arising from laboratory incidents and accurately assess the impact of the failure to make appropriate recommendations for remedial actions for follow-up.
11. Assume the role of corporate ERP system BPE when required.
12. Ensure regulatory compliance, perform GSK Management Monitoring audit and support Independent Business Monitoring (IBM) and external audits.
13. Ensure timeliness and accuracy of Pharmacopoeia & ATS review.

Qualifications:

1. At least a degree in chemistry.
2. At least 1-4 years' experience in an analytical environment, preferably in the pharmaceutical industry.
3. GMP and GLP knowledge.
4. Understanding product specifications and method of analysis.
5. Knowledge of laboratory instrumentation.
6. LIMS and corporate ERP system knowledge.
7. Laboratory support procedures.
8. Ways of working for new product introduction (NCE Support).
9. Regulatory requirements for method validation.
10. Good communication skills.
11. Basic financial management skills.
12. Basic knowledge of business processes within GSK.
13. People management skills.
14. Problem-solving skills (Troubleshooting skills).
15. Project management skills.

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