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 as part of new product introduction.
Key Responsibilities
- Draft, compile, review and update appropriate laboratory documents such as analytical methods and specifications, method validation/equivalency protocols/reports, local procedures and guidelines relating to GMP and operational framework of the laboratory
- 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 or improved testing technologies and/or methods for products and or cleaning processes.
- 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 or CAPA actions for follow-up
- Own and support Involve in the approving initiation and progression of 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 and change actions. Upon completion, review and ensure closure of changes.
Knowledge, Skills & Experience
- Minimum 3 - 5 years’ experience in an analytical environment, preferably in the pharmaceutical or regulated 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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Skills
Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations
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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.
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