The Position Purpose Maintain the site’s Right to Operate and enable excellence in manufacturing by providing validation support to the production organization that results in safe, high quality, and continuously improving production.
Own, execute and improve the validation lifecycle from Plan to Retire, for manufacturing processes and equipment. This includes, but is not limited to oversight of Equipment, Facility, and Utility Qualification, Cleaning Validation, Shipping Validation in partnership with Distribution, and administration of the Periodic Review and Revalidation Program. Accountable for ensuring compliance with PQS and HA requirements.
Key Responsibilities
Support the day-to-day operation of approved Validation SOPs / Plan / Policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility.
Develop Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation ...