Quality Analytical Chemist Manufacturing
4 weeks ago
We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
Working within the Analytical Services section of the Quality Department laboratories a Senior Analyst will provide high quality scientific and analytical expertise for a variety of pharmaceutical dosage forms. Ensure manufacturing departments are supported in their day to day operations with relevant deviation and process improvement oversight. Seek out improvement opportunities and make suggestions to management for changes in practice and technical innovation. Act as an Analytical expert on a wide range of projects. Will be expected to develop supervisory skills by undertaking more responsibility for the day to day operation of the laboratory.
Lead the execution of analytical method transfers between laboratories. Support and help to develop analytical validation strategies, ensuring all aspects of analytical development and validation are delivered to the required standard of science, quality and regulatory compliance in accordance with agreed timelines.
Assist with and ensure Quality Management System processes such as Change Controls, Deviations, CAPAs and Quality Risk management procedures are undertaken and progressed as required.
Plan, coordinate and conduct laboratory work to support analytical projects, this can be including analysis of raw materials, intermediates and finished products. Record, evaluate and present data generated during laboratory work both internally and by third parties, by applying expert scientific knowledge, demonstrating a practical approach and providing appropriate and innovative solutions.
Be proficient and proactive in the use of regulatory and other relevant guidelines, including pharmacopoeias, to ensure appropriate compliance within projects.
Provide appropriate and consolidated CMC or pharmaceutical analysis opinion to ensure successful project outcomes.
Minimum 5 years of years of experience in pharmaceutical testing laboratories.
Proven track record in analytical chemistry and or analytical development for drug product formulations as well as experience in CMC/regulatory guidelines and filings
Significant industrial experience working in or maintaining a GMP/GLP compliant analytical environment.
Experience with EU regulatory guidelines, quality management systems and quality risk assessments.
flexible benefits package
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