Senior CQV Specialist

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Responsibilities

• Provides technical and project leadership with a comprehensive understanding of the pharmaceutical industry design/build/validation processes and how they relate to Canadian, EU, and US FDA cGMP regulation requirements.
• Develops/reviews technical documentation for clients in regulated industries including qualification and validation protocols and reports, criticality assessments, risk assessments, validation master plans, user requirements specifications, standard operating procedures and quality plans and policies.
• Coordinate and execute testing of systems and processes from test protocols to assess compliance against requirements.
• Analysis of test data, including that derived from complex processes, and collection of samples, where required.
• Operation of testing equipment.
• Troubleshoots issues of diverse scope where analysis of data requires ev...