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- Tasks: As a Qualified Person, you'll certify products and ensure compliance with regulations.
- Company: Join Bespak, an award-winning pharmaceutical company focused on sustainable medical devices.
- Benefits: Enjoy 25 days holiday, generous pension contributions, private health insurance, and flexible working hours.
- Why this job: Be part of a growing team making a real impact in healthcare with a focus on sustainability.
- Qualifications: You need to be a registered Qualified Person with experience in pharmaceutical manufacturing.
- Other info: Located in beautiful Holmes Chapel, with excellent transport links and a commitment to inclusivity.
The predicted salary is between 68000 - 81000 £ per year.
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.
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.
Strictly No Agencies - Our in-house recruitment team manage all our vacancies.
Qualified Person employer: Bespak
Contact Detail:
Bespak Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person
✨Tip Number 1
Familiarise yourself with UK regulations and international standards relevant to the role of a Qualified Person. Understanding the specific legislation, such as SI 2012/1916 & 2004/1031, will demonstrate your expertise and commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience as Qualified Persons. Engaging in discussions about best practices and current trends can provide valuable insights and may even lead to referrals for the position.
✨Tip Number 3
Prepare to discuss your experience with audits and inspections in detail. Highlighting specific examples where you successfully navigated regulatory challenges or improved quality systems will showcase your capability and readiness for the role.
✨Tip Number 4
Research Bespak's recent developments and their sustainability initiatives. Showing that you are informed about the company's goals and values, particularly their commitment to carbon reduction and inclusivity, will help you align your responses with their corporate culture during the interview.
We think you need these skills to ace Qualified Person
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the responsibilities and requirements of a Qualified Person. Highlight your relevant experience in pharmaceutical manufacturing and compliance with UK regulations.
Tailor Your CV: Customise your CV to reflect the skills and experiences that align with the role. Emphasise your qualifications as a Registered Qualified Person and any specific achievements in quality assurance and regulatory compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention how your values align with Bespak's core values of being customer-focused, respectful, collaborative, and agile.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a Qualified Person.
How to prepare for a job interview at Bespak
✨Understand the Regulatory Landscape
As a Qualified Person, it's crucial to have a solid grasp of UK regulations and international standards. Familiarise yourself with SI 2012/1916 & 2004/1031, as well as current cGMP practices. This knowledge will not only help you answer questions confidently but also demonstrate your expertise in compliance.
✨Showcase Your Quality Culture Skills
Bespak values a strong quality culture, so be prepared to discuss how you've fostered this in previous roles. Share specific examples of how you've influenced cross-functional teams to prioritise quality and compliance, and how you've driven continuous improvement initiatives.
✨Prepare for Technical Questions
Expect technical questions related to batch certification, documentation review, and quality systems. Brush up on your experience with audits and inspections, and be ready to discuss how you've handled quality issues in the past. This will showcase your problem-solving skills and readiness for the role.
✨Align with Company Values
Bespak's core values are Customer Focused, Respectful, Collaborative, and Agile. During the interview, make sure to highlight how your personal values align with theirs. Share examples of how you've demonstrated these values in your work, which will show that you're a good cultural fit for the company.
