·Review and planning of validation for proposed processes – new, developed or existing related to facilities, utilities, equipment and cleaning
·Responsible for the statistical justification of sampling plans for validation projects
·Data collection involving processes such as mixing, cleaning, dispensing, lyophilization, sterilization, capping, labelling and various other testing methods
·Report writing to gather, evaluate and conclude a result
·Co-operation with other departments to ensure all testing required by validation is performed as planned
Please note that this job description is intended as a guideline – new duties and responsibilities will be incorporated as a matter of custom and practice as the role evolves
The Candidate:
Qualified to at least degree level, with at least a 2:1 in a life science discipline.
Excellent verbal and written communication skills
Good organizational skills
Previous experience with process validation
Previous experience with statistical sampling plans
Previous experience in Manufacturing or laboratory environment
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