About this 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 in an analytical environment, preferably in the pharmaceutical industry.
• GMP and GLP knowledge
• Understanding product specification and method of analysis
• Knowledge of laboratory instrumentation
• LIMS and corporate ERP system knowledge
• Laboratory support procedures
• Ways of working for new product introduction (NCE Support)
• Regulatory requirements for method validation
To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore #Li-GSK
Skills Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations
Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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