Define strategy, plan, and coordinate validation activities such as sterilization, hold time validation, APQ and APS.
Provides guidance on aspects of validations and qualifications.
Assure revalidation of manufacturing and sterilization processes.
Write, review and approval of sterilization, APS and other related validation plans, protocols and reports.
Participate in product transfer and system introduction teams.
Participate in system and process improvement / optimization projects.

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