To support Product Development and Clinical Supply. To troubleshoot, develop, transfer or validate of analytical test methods as applicable. You will be reporting to the Analytical Development Team Leader.
• To troubleshoot, develop, transfer and validate robust, sound analytical methods.
• To draft/ review test methods, validation protocols and reports as applicable.
• To prepare submission documentation in support of license applications.
• To take part in/lead laboratory investigations.
• To liase directly with customers and contract laboratories and attend conference calls as required.
• To attend internal project review meetings as required.
• To assist in the preparation for customer/ regulatory inspections.
• To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
• To analyse all raw materials, in process samples and finished products in a timely and efficient manner to ensure quality and efficacy of the product.
• To ensure that all work is carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
• To complete all documentation correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP. To peer review documentation as required.
• To perform additional team tasks as agreed to support effective running of the Business.
• To support all other on-going laboratory functions & requirements.
• Health and Safety:
• To ensure the requirements of the company’s Safety Statement are implemented.
• To continuously promote a positive safety culture by leading by example.
• To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
• To report any defects/hazards.
• Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
• At least two years’ experience working in a related technical environment.
• Strong analytical ability.
• Strong quality orientation.
• Ability to multitask and work under pressure, coping with more than one conflicting task at once.
• Adaptability – ability to maintain effectiveness in varying environments and with different tasks, responsibilities and people
• Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions.
• Knowledge of Project management skills.
• Proficient in the use of HPLC & associated problem solving.
• Working knowledge of Empower laboratory software.
• Proficient in dissolution testing.
• Proficient in the use of electronic document management systems.
• Proficient in Technical report writing.
• Strong Safety awareness.
• Knowledge & proficiency of Microsoft products for example MS Excel, Word & Project, Power-point.
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