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Bespak Europe ltd

Qualified Person

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  • GB
    United Kingdom
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À propos

This is an exciting opportunity for a Qualified Person to join Bespak on a permanent basis, onsite at the Holmes Chapel site, CW4 8BE. The salary for this role is £80k to £90k plus a discretionary annual bonus. 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. Days shift Pattern – Monday to Friday (8.30am to 9am start / 4.30pm - 5pm finish. (3:45pm finish on Friday possible) There is some flexibility on start and finish times. As a Qualified Person (QP), you will be responsible for the certification and release of Commercial Finished Products and Investigational Medicinal Products (IMPs) manufactured and packed at the Bespak Holmes Chapel site for worldwide markets. You will ensure compliance with UK regulations and international standards while providing quality and compliance leadership across site operations. Bespak in Holmes Chapel is an Investors in People Silver Award-winning pharmaceutical CDMO with over 350 employees, currently going through a period of significant site expansion. We are investing heavily to increase our capacity for developing and manufacturing sustainable pMDIs (asthma inhalers) with greener propellants, meeting the evolving standards of the industry, while providing comprehensive development, manufacturing, filling, and finishing solutions for a range of medical devices, including SMIs, DPIs, nasal sprays, and medical check valves. As a Qualified Person, your duties will include: * Certify commercial and clinical product batches in line with UK legislation (SI 2012/1916 & 2004/1031). * Review and approve batch-related documentation, GMP records and Quality Agreements. * Develop and review SOPs, validation protocols, change controls, complaints, and specifications. * Monitor, maintain and improve quality systems and ensure readiness for inspections (MHRA, FDA). * Incorporate Regulatory trends and changes into the Holmes Chapel site. * Act as a QA lead in cross-functional improvement initiatives and technical investigations. * Conduct self-inspections and vendor audits, driving continuous improvement and CAPA effectiveness. * Provide GMP coaching to site teams to support right-first-time performance. * Provide rapid escalation and resolution of quality issues. * Proactively identify risks and mitigations * Support Customer and Regulatory Inspections. Qualified Person, beneficial key skills and experience: * Registered Qualified Person under current UK legislation. * Experience in pharmaceutical manufacturing and QP-related duties. * Strong understanding of cGMP and global regulatory requirements. * Experience across various dosage forms and product lifecycle stages is desirable. * Skilled in fostering a strong quality culture and influencing cross-functional teams. * Experience with audits and inspections and communicating with regulatory agencies Qualified Person, 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. Strictly No Agencies - Our in-house recruitment team manage all our vacancies

Compétences idéales

  • QA
  • United Kingdom

Expérience professionnelle

  • Healthcare

Compétences linguistiques

  • English
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