Exciting Opportunity with a Leading Biopharmaceutical OrganizationWe're currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
DutiesDevelopment of validation plans, process performance qualifications for vial and syringe filling.Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business processes related to technology transfer.Participate in process validation cross-functional teams at the site to ensure adherence to required policies and procedures and be responsible for delivering against organizational goals and project milestones.Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.Actively communicate across functions and sites and be a strong collaborator with all functional groups at the receiving site, sending site, and corporate functions.Assist in the development of any existing validation program to ensure continued compliance with the necessary regulations and input to site validation guidance documents.Collate and report on relevant shipping and filter validation.Assist in deviation and exception resolution and root cause analysis.Contribute to product quality assessments and process flow documents.Education & ExperienceThird level Bachelor's degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience.Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or ****** for further information.
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