
Biopharmaceutical Validation Specialist
1 week ago
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- Design and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
- Develop and implement execution/development of change controls.
- Solve technical issues encountered during study execution.
- Engage with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
- Provide technical input into quality notifications by authoring/reviewing/approving investigations.
- Analyze system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
- Improve continuous improvement through Lean Six Sigma methodologies.
- Represent the validation team at global technical forums.
- 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.
- Document completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
- Support regulatory audits and submissions as required.
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