Responsibilities:
- 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.
Requirements:
- Significant 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.
What’s on offer:
- Competitive hourly rate
- Stable contract duration
About NRL:
NRL connects global engineering companies with the right people to help their businesses grow and thrive, connecting organisations and candidates that share the same values and drive to succeed. As we progress your application our team of talented recruiters will be on hand to help you explore the role and answer any questions you have.
We welcome applications from every walk of life and are committed to driving diversity and inclusion within the industries we support. That’s why our Member Committed to Diversity status with the Association of Professional Staffing Companies is so important to us.