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Katalyst Healthcares and Life Sciences

Validation Lead

Katalyst Healthcares and Life Sciences, Boston, Massachusetts, us, 02298


Responsibilities:

Should have solid validation lead experience working for pharmaceutical companies as Val lead. Should have great communication and coordination skills between internal team and customers across shores. Should have good track record in managing teams to successful project delivery. Should have solid experience in creating/executing best practices, guidelines, checklist GxP projects execution. Worked in Life Sciences vertical both GxP and non GxP space. Familiar with Life science business process flow. End to end validation and testing deliverables uthor, review, approve GxP/Risk Assessment, Val Plan, IQ, OQ, PQ, Val Summary, Traceability matrix, URS, FRS, Design documents. Should have good understanding and experience on execution and managing GxP projects and deliverables. Experience in systems like LIMS, MES, etc will help.