Description
QAV Engineer to join a new team supporting the current CQV team with the execution activities for an initial 6 month contract.Role and responsibilities:
- Reporting to the CQV Lead.
- Change control assessment and review for all downstream and upstream equipment.
- Review and approval of all equipment documentation.
- Authoring, review and approval of appropriate Validation related procedures and philosophy documents.
- A clear understanding of cGMP requirements of process 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 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 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.