Description
Global healthcare company is seeking a Validation Manager for their brand new state of the art manufacturing site based in North Dublin.Day to Day:
- Manager with responsibility for leading the validation and documentation control area.
- Provide validation expertise and direction to maintain validated status for existing manufacturing and laboratory equipment and systems in the Pilot Plant
- Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, facilities and laboratory equipment, and approves validation documentation
- Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment
- Applies expertise and understanding of equipment operation to manufacture of development and clinical batches as required
- Maintain the Site Validation Master Plan and Cleaning Validation Master Plan
- Coordinate team activities to ensure schedule adherence, site permanent inspection readiness and continued site compliance
- Assist in the development of a continuous monitoring strategy using statistical analysis, to measure, control and improve on product and process robustness throughout product life cycle.
Requirements:
- The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast paced environment.
- Third level qualification eg Science/Engineering minimum of degree, with 7+ years relevant experience in validation required.
- High proficiency in Microsoft Excel/Powerpoint/MS Project etc.
- Proficiency in statistical software packages.
- Previous experience in complex drug product / medical devices and / or respiratory a distinct advantage.
- An ability to work flexibly in a changing environment. An ability to multi-task, good attention to detail and priority management essential.
- Strong technical ability including methodical approach to problem solving and strong technical writing skills.
- A good understanding of the requirements of Good Manufacturing Practices and Quality systems.
The role also includes an attractive salary and benefits package.
If you are interested in this role please contact me Anna Mooney or reply below with an up to date CV.