Description
Validation Engineer - Protocols - API- GAMP - Cork, IR
This project requires a highly skilled seniorValidation resource as the person would have to advise and co-ordinate documentation/people with other leads within the project. Also experience of Gamp/CSV would be critical, as all validation documentation would be written to Janssen specifications for projects. The documentation will include validation plans, impact assessments, DQ, IQ, OQ, PQ and FQ protocols and validation reports/matrices. The successful candidate will also be required to support the execution of these protocols. The Validation resource will be expected to co-ordinate the validation activities.
The ideal candidate will have a number of years experience in a regulated API environment. They will be a self-starter and capable of working on their own initiative, as well as working well as part of a team. This position requires a hands on attitude to Validation/Commissioning/Qualification techniques.
Non Technical Skills and Additional Details
The ideal candidate will have a number of years experience in a regulated API environment. They will be a self-starter and capable of working on their own initiative, as well as working well as part of a team. This position requires a hands on attitude to Validation/Commissioning/Qualification techniques.
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