Description
Would you like to work for one of the largest CMO's in the world? Well, look no further as we may have the opportunity for you!QAV Engineers are required to join a global pharmaceutical company located in the South West UK for an initial 6 month duration.
A fast paced and exciting environment which is seeing a lot of internal investment currently this is the chance to get involved with a global client who is going from strength to strength.
With a number of exciting refurbishment projects in the pipeline this is a great chance to be involved in the full project life cycle with the opportunity to move into other projects and areas of the business.
Role and responsibilities:
- 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
- The successful candidate will 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 UK, US and EU GMP regulations, and the principles of qualification and validation would be beneficial, but not essential
- The successful candidate must be able to demonstrate excellent time management and organizational 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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