Ensures all validation activities are performed in compliance with applicable cGMP/GxP regulations, industry standards, and site procedures. Collaborates with cross-functional teams including Manufacturing, Engineering, Quality Assurance, Quality Control, Supply Chain, and Project Management to support operational excellence, product lifecycle management, continuous improvement initiatives, and successful project delivery.
Key Duties:
- Develop, review, approve, and maintain validation lifecycle documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, reports, and periodic reviews.
- Coordinate and execute commissioning, qualification, and validation activities for facilities, utilities, equipment, processes, cleaning systems, and computerised systems.
- Ensure compliance with regulatory requirements, internal quality standards, and data integrity principles.
- Support change control, deviation investigations, CAPA implementation, and impact assessments related to validated systems.
- Provide validation expertise during audits, inspections, and regulatory submissions.
- Drive continuous improvement of validation processes and site compliance programmes.
- Work closely with project teams to deliver validation activities within agreed timelines and budgets.
- Support product transfers, process improvements, and lifecycle management activities.
Core Competencies:
- cGMP/GxP compliance
- Commissioning, Qualification & Validation (CQV)
- Process and Cleaning Validation
- Computer System Validation (CSV)
- Risk Management
- Change Control and CAPA
- Technical Writing and Documentation
- Cross-functional Collaboration
- Continuous Improvement
- Regulatory Inspection Readiness
25 days annual holiday + bank holiday + Buy/Sell Scheme | A generous employer pension contribution | Private medical insurance | Private dental Insurance | Permanent Health Insurance | Group life insurance | Free will service | Active well-being programme | Recognition awards | Free Parking
Bespak Holmes employs over 300 people and are a pharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers development and manufacturing solutions for a variety of medical products. Our products include medical devices such as pressurized metered dose inhalers (pMDI), soft mist inhalers (SMI), dry powder inhalers (DPI), nasal sprays and medical check valves.
Sustainability is central to how Bespak operates, engages with its people and communities, and designs safe medical devices for the patients who rely on them.
A full job description can be downloaded on the application Screen.
Our core values are, Customer Focussed, Respectful, Collaborative, and Agile, these are woven into the fabric of our business and the values we measure ourselves by.
We are flexible. We understand that there is a life outside of work, so we aim to support you in attaining a happy work/life balance. To cater for employees’ individual circumstances, and where possible, we agree flexible working arrangements.
We value our inclusivity as we believe diversity should be embraced and celebrated. We live and work by these values and that’s what makes our company a great place to work.
We are proud to be a Disability Confident employer. We will support you throughout the recruitment process with any adjustments you require therefore please contact the Recruitment Team if you require support.
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