Bachelors Degree in Analytical Chemistry
Minimum 8-10 years operational analytical experience in a pharmaceutical industry/GMP manufacturing environment.
- Experience in implementing laboratory systems and/or equipment with a focus on analytical instrumental analysis.
- Strong communication and negotiation skills (oral and written).
- Results-driven individual with a strong customer and quality focus.
- Experience in working in an international and multidisciplinary environment.
- Good interpersonal and leadership skills.
- Computer literate (Microsoft Office) with demonstrated skills in the use of word processing, spread sheets, databases & information management systems
Provide expert knowledge in the areas of Analytical Science and Technology to ensure that laboratories are equipped with technology that is state-of-the art and fit for purpose. Supervise AS&T laboratory operations to support the implementation of compliant, state-of-the-art methodology and instrumentation, troubleshooting, best practice, experimental design and quality systems within the AS&T network. Develop a strategy and implementation plan for analytical methodology and equipment, which enables efficient and compliant laboratory operation.
• Provide expertise in the areas of Analytical Science and Technology; method development and validation, degradation pathway and state-of-the-art methodology and equipment.
• Develop an implementation strategy for analytical methodology to ensure best practice and compliance with regulatory expectations and GSK internal requirements.
• Support operation and qualification of analytical laboratories and equipment at site level with expert knowledge and state-of-the-art processes and systems.
• Implement continuous improvement and laboratory excellence initiatives as defined by the AS&T network.
• Support the OTC Quality Control network and lead activities related to analytical methods and instrumentation, as well as troubleshooting and resolving investigations to facilitate solutions to complex challenges.
• Support the sites in the preparation, management and follow up of Health Authority inspections with regards to analytical methodology, equipment and systems. Review and monitor action plans for addressing audit observations related to analytical technologies. Ensure that learning's from inspections and audits are effectively shared.
• Lead the definition and implementation of appropriate key quality indicators to monitor performance in analytical laboratories.
• Work seamlessly with AST central laboratory in Lincoln to prioritize and develop state of art methodologies for key products at Lincoln. Build effective partnership across the quality network at site and global level, to effectively implement the best methodologies and practice to Lincoln site and globally.
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