Description
A good understanding of either the pharmaceutical or medical device industry is essential. You must also have experience in carrying out validation activities, adhering to GxP guidelines, and meeting the FDA's rule, 21 CFR Part 11.Excellent attention to detail is essential and the individual must be competent in the creation of documentation including validation master plans and reports, and confident in carrying out testing and qualification activities, such as pre-delivery testing, IQ, OQ
You will be responsible for carrying out a wide range of validation activities including creating initial validation master plans, performing design qualification activities, pre-delivery testing, IQ, OQ and PQ, writing SOPs, and producing validation reports.
You will be responsible for maintaining an up-to-date understanding of the legislation and guidelines governing the industry, and sharing your expertise with colleagues and customers.