Senior Q&V Specialist

Essential Qualifications

• The holder will normally be expected to be qualified in a technical or scientific area which is relevant to the role. This may be through a formal educational / qualification route or via relevant experience and training obtained through practical application. It may also be a combination of both.

Essential Experience

Key Roles/Responsibilities

• 1) Provision of planning, support and guidance for validation projects. This includes:
• · Ensuring continuous improvement of validation policies, procedures, templates and working practices.
• · Oversight of project plans and milestones in conjunction with project teams in order to meet compliance and customer needs.
• · Coordination, resource management and facilitation of validation projects.
• · Provision of validation expertise, advice and guidance to the site, Q&V team and 3rd parties to ensure compliance with site policy and procedures.
• · Establish validation documentation in conjunction with project teams and in compliance with relevant SOPs and good practice.
• · Facilitation of the review and approval of validation documents.
• · Practical support during protocol execution and reporting where required and appropriate.
• 2) Oversight, metric reporting and provision of practical support to Periodic Review activities.
• 3) Ensure management of the SVMP Inventory and SVMP Schedule with information provided by validation practitioners.
• 4) Generation of training packages and delivery of training on validation related topics.
• Maintain and develop knowledge of current regulatory expectations and industry best practices with respect to validation.
• Competencies:
• Attention to detail
• Thoroughness
• Planning and Prioritisation
• Good communication skills – written and verbal
• Problem solving