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We have an opportunity for someone to provide leadership and management to a team within a company based just outside Cambridge. This is a contract role of 12 months duration. You will be responsible for co-ordinating and providing validation expertise in the lifecycle management of all aspects of computer system validation, qualification and data integrity. For more information please contact Polytec.
* Degree in a science, engineering, computing or pharmaceutical related subject
* Strong knowledge of working within a Quality Management System and cGMP and experience of working within a cGMP environment
* High level of qualification/validation knowledge
* Ability to develop good relationships with customers and stakeholders
* Experience of working within a quality role
* Strong written and verbal communication skills
* Ability to motivate, engage and develop individual team members
* Awareness of statistical analysis techniques and software and ongoing development of knowledge in this area
* Understanding of data integrity principles
* Understanding of current industry requirements of cGMP, Annex 11, GAMP, 21 CFR Part 11.
* Experience of working on GAMP related projects for multiple aspects of IT and/or process control systems.
* Current regulatory knowledge in the field of computer systems validation
[ Haverhill, Suffolk, Hourly rate: £neg. | vacancy reference : 32545 ]