· Ensure training/hands-on on newly developed Analytical Methods as per need and quality processes in place (local and/or general)
o From R&D SME
o to QC lab person (Lessines)
· Review draft Method of Analysis for completeness and feasibility implementation in QC lab.
· Participate to transfer/validation of analytical method according to study protocol. Ensure all reagents, raw materials and equipment are available to run testing design, perform experiments, document activities in an appropriate way and follow-up with responsible person in case of deviation or failed acceptance criteria
· Review transfer/validation reports as well as associated Method of Analysis to ensure data accuracy and completeness
· Adhere to the quality system requirements and ensure GMP and GDP standards; also adhere to general and specific environmental, health and safety guidelines.
· Work with software in place (e.g : SIMS, Equipments' software, statistical tools (e-noval, …)
· Perform laboratory testing in a qualified environment following procedures (equipment and analytical procedures) and local or global processes, with respect to timeline and planning assigned by team lead
· Facilitate the coordination of the validation/transfer activities between R&D and QC laboratory.
· Collaborate with R&D Analytical SME's, QC Lab Personnel and Analytical Leads to ensure project schedules are met.
· Understand and effectively communicate to team members about potential road-blocks within area of expertise (Analytical Method transfer/validation)
· Good knowledge of chemistry and analytical techniques (liquid/gas chromatography, titrations, Karl-Fisher, AAS/AES/FES, ICP, and mass)
· Good knowledge of method validation/verification/transfer design and associated regulations
· Knowledge of GMPs, FDA, ICH, and compendial guidelines.
· Problem-solving expertise.
· Ability to assess risk and mitigate in every task
· Demonstrated in-depth experience in method development, validation of minimally (below area of expertise being covered ideally by the combined expertise of the two positions)
o HPLC, GC, KF, and titration methods
o AAS/AES/FES, ICP, and mass methods
· Good interpersonal skills, and ability to adapt to diverse environments (R&D and QC environment).
· Capable of analyzing and proposing solution for analytical problems through innovative thought and experience.
· English Fluent, French is a very big plus
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