Senior Q&V Specialist

SRG; Stirling; On-site; GBP 65,000 - 90,000; Full time

Job summary

SRG is seeking a Senior Qualification & Validation (Q&V) Specialist for a global pharmaceutical manufacturer with a GMP-regulated site in Central Scotland. You will own key Q&V quality system elements, coordinate validation projects and maintain compliance with UK/EU/US GMP/GDP, ICH, ISPE and other requirements.

You will lead validation documentation, support protocol execution and Periodic Review activities, and develop training packages while staying current with regulatory expectations and

Qualifications

• Technical or scientific qualification relevant to the role or equivalent practical experience.
• Strong technical knowledge of qualification and validation systems.
• Excellent written and verbal communication skills.
• Experience supporting audits and regulatory inspections.
• Ability to plan, coordinate and deliver validation projects.

Responsibilities

• Provide planning, support and guidance for validation projects and SOPs.
• Oversee project plans and milestones to meet compliance.
• Coordinate resourcing and facilitate validation projects across the site.
• Provide validation expertise, advice and guidance to the site, the Q&V team and third parties.
• Develop validation documentation and facilitate review and approval of validation documents.
• Offer practical support during protocol execution and reporting.
• Provide oversight, metric reporting and practical support for Periodic Review activities.
• Manage the SVMP Inventory and SVMP Schedule using information from validation practitioners.
• Develop and deliver training packages on validation-related topics.
• Maintain up-to-date knowledge of regulatory expectations and industry best practice in validation.

Skills

Qualification systems

Validation processes

Documentation skills

Communication skills

Training delivery

Project planning

Audits & inspections

Team collaboration

Education

Science/technical degree

Tools

Computer systems

Job description

Senior Qualification & Validation (Q&V) Specialist

Our client is a global pharmaceutical manufacturer with a major GMP-regulated production site in Central Scotland. As part of continued investment in their Quality organisation, they are looking to appoint a Senior Qualification & Validation Specialist to strengthen governance and compliance across site Q&V and Periodic Review activities.

The Role

Reporting into the site Quality function, you will take ownership of key Q&V quality system elements, coordinating, maintaining and promoting Q&V compliance across the site. You will lead and support continuous improvement of related quality and operational systems, ensuring the site and its functions remain compliant with GxP regulations and applicable quality guidelines, including UK/EU/US GMP/GDP, ICH, ISPE and other region-specific requirements.

Key Responsibilities

• Provide planning, support and guidance for validation projects, including continuous improvement of validation policies, procedures, templates and working practices.
• Oversee project plans and milestones alongside project teams to meet compliance and customer requirements.
• Coordinate resourcing and facilitate validation projects across the site.
• Provide validation expertise, advice and guidance to the site, the Q&V team and third parties, ensuring compliance with site policy and procedures.
• Develop validation documentation with project teams in line with relevant SOPs and good practice, and facilitate review and approval of validation documents.
• Offer practical support during protocol execution and reporting as required.
• Provide oversight, metric reporting and practical support for Periodic Review activities.
• Manage the SVMP Inventory and SVMP Schedule using information from validation practitioners.
• Develop and deliver training packages on validation-related topics.
• Maintain up-to-date knowledge of regulatory expectations and industry best practice in validation.

What You'll Bring

• A technical or scientific qualification relevant to the role, or equivalent experience gained through practical application.
• Strong technical knowledge of qualification and validation systems.
• Good computer system skills.
• Strong written (technical writing) and verbal communication skills.
• Presentation and training delivery experience.
• Strong planning and prioritisation skills.
• Experience supporting client audits and regulatory agency inspections.
• A collaborative, team-oriented approach.

Key Competencies

• Attention to detail and thoroughness
• Planning and prioritisation
• Strong communication skills, written and verbal
• Problem solving