This is an 11-month contract
Provide Quality oversight on the design and qualification activities as part of the design, construction, qualification, and start-up of the new BioNX facility at the site.
• Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
• Quality SME for the execution and reporting phases of the qualification and validation activities associated with the BioNX facility.
• Review and approve all documentation where required specific to Qualification / Validation activities.
• Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner
• Oversee the Project Change Management Process and approve Project Change Requests where required.
•Level 8 degree required within Science/ Engineering
• 6-8+ years’ experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
• Strong experience with Validation in project related activities i.e., Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
• Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
• Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
• Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
• Track record of utilizing Risk Based Approaches to Qualification / Validation activities.
• Strong track record of identifying, escalating, and correcting compliance issues and implementing process improvements.
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