Description:
They are currently searching for a Validation Lead to join the Quality Dept, for a permanent role at their Leinster site.
The Position
Key responsibilities would include:
- Responsible for leading the comprehensive validation support to all areas on site; Manufacturing and QC laboratory equipment, Automated Control Systems, Instrumentation, Facilities, Utilities, Manufacturing processes and Cleaning processes.
- Ensure that all systems conform to relevant regulatory requirements as well as company specifications and standards.
- Responsible for preparing, reviewing and approving Validation Documentation, such as URS, RTM, Risk Assessments, IQ, OP and PQ, ensuring highest EHS Standards are obtained.
- Responsible for field execution of Commissioning, Installation & Operational Qualifications (IQ/OQ).
- Responsible for the coordination of vendor packages to achieve streamlined Commissioning & Validation.
- Responsible for review of vendors as well as executing commissioning and validation documentation
- Responsible for initiation and completion of deviations/exceptions, CAPAs, and change controls for process systems including investigations relating to equipment performance.
- Provide technical leadership for all validation activities
The Person
- Level 8 Degree in Science, Engineering or related Technical-degree.
- 7-8 years of Pharmaceutical manufacturing experience.
- Experience in commissioning, qualification and validation activities in a GMP environment, including the generation of procedures, plans and policies.
- Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern Validation practices.