The candidate must have a strong technical knowledge of analytical techniques and strong knowledge of related laboratory equipment in one or more of the following areas:ResponsibilitiesQualification of analytical equipment and related testing functions, for example HPLC, Spectrophotometry, Nephelometry, Endotoxin, Cell Culture and Total Sampling and testing coordination during plant and laboratory utility qualificationCo-ordinates & plans activities related to the successful transfer of Analytical Methods for relevant NMEs, including Raw material, Utilities, In Process, Final Bulk and Final product analytical testing and samplingSupport and Implementation of Analyst Training programsPartners with other Departments and Team Leaders to ensure that activities related to QC are completed in an efficient mannerQualifications and ExperienceBachelor’s Degree in Chemistry, Biochemistry, Microbiology or science related field4-6 years related experience in biopharmaceutical or pharmaceutical industry and/or an equivalent combination of education and experienceWorking knowledge of regulatory requirements, policies and guidelinesExperience with Quality Control document reviews and regulatory inspection processesWorking knowledge of Quality systemsStrong technical knowledge in and experience with QC analytical testing methods and equipmentKnowledge of cGMP regulations and FDA/EU guidance
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