Senior CQV Specialist

Responsibilities

• Provides technical and project leadership with comprehensive understanding of pharmaceutical industry design/build/validation processes and their relation to Canadian, EU, and US FDA cGMP regulation requirements.
• Develops and 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, SOPs and quality plans and policies.
• Coordinates and executes testing of systems and processes from test protocols to assess compliance against requirements.
• Analyzes test data, including that derived from complex processes, and collects samples where required.
• Operates testing equipment.
• Troubleshoots issues of diverse scope where data analysis requires evaluation of identifiable factors.
• Provides recommendations on equipment/process oper...