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You will support quality assurance, validation and computerised system validation (CSV) activities across projects and operations. You will work with cross-functional teams to plan and deliver validation work, resolve quality issues, and support inspections. We value practical problem solvers who communicate clearly, act with integrity and help teams move forward.
Job Responsibility:
Lead planning and execution of validation and CSV activities for projects and operations, ensuring fit for purpose documentation
Provide quality oversight and technical leadership for validation and computer system validation (CSV) including management and approval of quality notifications
Work with project teams, engineering, IT and operations to support system design, testing, release and handover
Support internal and external inspections by preparing evidence, responding to queries and implementing agreed actions
Apply risk-based approaches to validation decisions and document rationale clearly for stakeholders
Drive continuous improvement of validation processes, templates and tools to increase efficiency and compliance
Requirements:
Demonstrable experience in validation or quality assurance in a regulated environment
Experience with computerised system validation or similar lifecycle activities
Working knowledge of good manufacturing practice (GMP) and quality management systems
Degree in a relevant scientific, technical or engineering discipline, or equivalent experiential background
Experience applying GAMP principles and knowledge of data integrity requirements
Practical experience supporting inspections and regulatory interactions
Proven track record in delivering validation
Experience using risk assessment tools and producing fit-for-purpose risk documentation