Job Description
A Head of Quality Assurance required by Careerwise recruitment to work with our Dublin based pharmaceutical client.
Role of this position
1. Lead and Mentors the QA Operations team to operate independently and cohesively to deliver excellence in Quality and Compliance.
2. Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to manufacturing and product supply.
3. Be the quality point person, providing guidance and feedback on quality assurance issues.
4. Ensure documentation, investigations and reports are reviewed and approved promptly, highlighting and assisting in the resolution of issues determined by the level of risk.
5. Oversee the application of Risk Management Principles at the facility.
6. Ensure schedules for approval of GMP documents are maintained to meet the needs of Commercial Operations.
7. Provide comprehensive QA support to manufacturing, engineering, utilities, supply chain and material movement (including cold chain) for commercial products.
JOB REQUIREMENTS
8. QP qualified highly desired.
9. 15 years relevant experience in the pharma industry or a related field.
10. 3 years managerial experience.
11. Aseptic manufacturing experience is essential
12. Knowledge of cGMP requirements for pharmaceutical manufacturing required.