About the Role
We are currently recruiting for an exciting opportunity.
This is an excellent position for anyone looking to join a leading biopharmaceutical organization based in Carlow who excels in their field.
Key Responsibilities
1. Design and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
2. Develop and implement execution/development of change controls.
3. Solve technical issues encountered during study execution.
4. Engage with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
5. Provide technical input into quality notifications by authoring/reviewing/approving investigations.
6. Analyze system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
7. Improve continuous improvement through Lean Six Sigma methodologies.
8. Represent the validation team at global technical forums.
9. Ensure compliance of Global Policies, Procedures and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
10. Document completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
11. Support regulatory audits and submissions as required.