Commissioning & Qualification Manager
Eastgate Engineering is seeking to recruit a Senior C&Q Manager for a Dublin, Ireland, based Pharmaceutical project.
- Take ownership of the required processes relating to commissioning and qualification, ensuring compliance with all applicable regulatory and internal Quality standards and industry best practice.
Position roles & responsibilities:
- Lead and direct the Commissioning and Qualification execution team based at a Pharmaceutical Facility, Dublin, Ireland and manage the C&Q documentation lifecycle.
- Review, develop and take ownership of the required processes relating to commissioning and qualification, ensuring compliance with all applicable regulatory, functional and internal Quality standards and industry best practice with zero impact to the process development, facilities or operations functions.
- Developing & implementing compliant processes covering all aspects of the equipment lifecycle VMP, VPP‘s, specifications, DQ, FAT/SAT, IQ, OQ, PQ & PPQ, requalification and periodic review.
- Work with the project management team to plan and schedule the required qualification activities to maintain project schedule by the most appropriate personnel.
- Manage and support service or equipment vendors when undertaking qualification as required to ensure that applicable standards are adhered to.
- Integrate with and interact across all relevant functions including Maintenance, Facilities, Quality Assurance, Production and Supply Chain to ensure compliant C&Q delivery to the assets across the site.
The Commissioning and Qualification Manager reports to the Project Manager
Significant experience of leading C&Q teams in the pharmaceutical industry essential including bio-pharmaceutical and utility qualification activities and documentation requirements. 7 – 10 years in similar role preferred
- Degree level qualification, science or engineering discipline preferred.
- This role requires frequent interaction between end client and sub-contractors, and as such the ability to form relationships across the organisation is essential for success
- Able to influence, persuade, negotiate and compromise.
- Able to chair and lead discussions.
- Understands that position is the technical leader for C&Q activities on this project.