Description
One of the top 10 best companies to work in Ireland is looking for more engineers for their large scale new facility north of Dublin. Is this you?A QAV Engineer is required to join a Global biotech company located in Dublin for an initial 9 month contract.
This is an exciting project as there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Role and responsibilities:
- QAV Engineer for Upstream Equipment (Bioreactor Skids, Single Use Mixers, Single Use Bioreactors, Transfer Panels, etc.)
- Review and approval of all CQV deliverables including QRA, DQ, RTM, FAT, IOC/IOQ and associated Final Reports.
- MC Walkdown signoff on Quality Impact Systems.
- Review and approval of Project Change Controls
- A clear understanding of cGMP requirements of equipment and qualification.
- A knowledge of ICH guidelines, FDA regulations and a working knowledge of GAMP guidelines would prove advantageous.
- Hold a BSc in Biochemistry (or science related discipline), or a BEng.
- Previous experience in a pharmaceutical environment within a Validation role.
- A strong working knowledge of US and EU GMP regulations, and the principles of qualification and validation would be beneficial, but not essential.
- Must be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task.
- The QAV Specialist will be required to work on his/her own initiative as much as working as part of a team.
- As such excellent interaction, communication and presentation skills are necessary to be successful in the role.
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