Qualification & Validation Specialist
2 days ago
Bespak is looking for a Qualification & Validation Specialist CQW for this permanent role on the Holmes Chapel site, CW4 8BE. The salary for this role is £60K per annum. Other benefits you will receive are 25 days leave plus bank holidays, discretionary annual bonus, generous 10% pension contribution, onsite free parking, and medical / dental / health / life assurance.
Shift Pattern
- Days 37.5 hours a week. 7.75 hours Monday to Thursday with a flexible start time between 8am and 9:30 am. 6.5 hours on Friday with an expected finish at 3:45.
Once you click apply, you will be redirected to our company website to make your application.
As the Qualification & Validation Specialist you will be responsible for leading and executing qualification and validation activities to support manufacturing operations, ensuring equipment, systems, and processes comply with regulatory, quality, and business requirements. This role is vital to upholding product quality and patient safety by applying current regulatory guidance and industry best practices, including the MHRA Orange Guide, EU Eudralex Annexes 11 and 15, and ISPE GAMP. You will also contribute to business as usual activities cross functional project delivery, continuous improvement and on going compliance of validated systems across their lifecycle.
As the Qualification & Validation Specialist, your duties will include:
• Validation lifecycle across all stages.
• Equipment Utility & Facility Qualification.
• Process Cleaning Validation ( DQ, IQ,OQ,PQ).
• Regulatory Compliance.
• Documentation & Reporting.
• Stakeholder Management.
• Computer System validation.
• Ethical Accountability.
• Environmental & Safety Leadership.
As the Qualification & Validation Specialist beneficial key skills and experience:
• Degree qualified in a relevant scientific or engineering discipline (level 6 and above).
• Over 10 years' experience in validation roles within the pharmaceutical industry or life sciences sector.
• Extensive hands-on experience across equipment, utility, facility, process/cleaning, and computerised system validation.
• Proven track record in leading validation projects, supporting regulatory inspections, and driving continuous improvement in compliance practices.
• Strong analytical and problem-solving skills to assess risk and implement effective validation strategies.
• Able to work both independently and collaboratively in a fast-paced, regulated environment.
• High attention to detail with a methodical and structured approach to documentation and regulatory compliance.
Qualification & Validation Specialist, benefits.
25 days holiday + bank holidays + Buy/Sell Scheme | A generous employer pension contribution | Private medical insurance | Private dental Insurance | Permanent Health Insurance | Group life assurance | Free will writing service | Active well-being programme | Recognition awards | Free Parking.
Holmes Chapel is a beautiful village in Cheshire with excellent transport links via its railway station on the Crewe-Manchester Line, proximity to the motorway network and Manchester Airport. The National Parks of the Peak District, Lake District and Eryri (Snowdonia) are within easy reach. The village has a population of nearly 7,000 and offers various amenities, including supermarkets, shops, restaurants, schools, and a GP practice.
As an ethical employer we align our BZero sustainability initiative to the SBTI certification which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485.
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 positive employer. We will support you throughout the recruitment process with any adjustments you require therefore please contact the Recruitment Team if you require support. By applying to this role, you are giving consent to Bespak Limited to process your personal data for employment/recruitment purposes only. All personal and sensitive data processed to Bespak is protected under GDPR regulations. To find out more about our privacy policy please visit our website or contact the local HR team.
Please be advised that we are working with our trusted recruitment partner,
Kinetic PLC,
to manage this recruitment process. As such, a consultant from their team may screen your application and contact you directly on our behalf to progress your application.
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