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- Tasks: Support Quality Assurance activities for pharmaceutical products and ensure compliance with regulations.
- Company: Join a long-established global pharma company at their EU HQ in the Home Counties.
- Benefits: Enjoy a competitive salary and an excellent benefits package.
- Why this job: Be part of a dynamic team, mentor others, and make a real impact in healthcare.
- Qualifications: Must have full QP qualification and experience with quality assurance in pharmaceuticals.
- Other info: Applicants must be entitled to work in the UK; reference job 143532 when applying.
The predicted salary is between 43200 - 72000 £ per year.
Jim Gleeson is recruiting for a Qualified Person, to join a long-established global pharma company, to be based at their EU HQ in the Home Counties.
The Role:
You will support the Associate Director Quality Operations in the implementation and maintenance of Quality Assurance activities relating to product support used for the manufacture, packaging, testing, storage and distribution of marketed products.
Responsibilities:
- To carry out the legal duties of a Qualified Person (QP) as specified under EC directive 2001/83/EC as amended and 2001/20/EC
- Review and disposition batches for marketed products in accordance with the UK Code of Practice for Qualified Persons
- QA review and approval of master and executed batch records and associated documents
- Preparation, review and approval of SOPs, review and approval of qualification/validation protocols and reports
- Participation in the execution of the internal and external audit process according to the audit schedules
- Ensuring the ongoing compliance of the manufacturing facility, including implementation of new GMP requirements
- Ongoing training, coaching and mentoring of staff in GMP and compliance
Your Background:
- Full QP qualification
- Experience with oral solid dose or sterile products
- Extensive knowledge and experience of Quality Assurance, Quality Systems, GMP guidelines and an understanding of the manufacture and packaging of pharmaceutical products
- Ability to establish and maintain effective working relationships and communication links within the manufacturing unit, affiliated organisations and other customers
- Ability to interpret complex data and present key findings
- Ability to conduct audits internal and externally
- Ability to act as a mentor in support of Quality staff development
Salary:
- Competitive with an excellent benefits package
Apply :
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 143532 in all correspondence.
If this position isn\’t suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.
Qualified Person employer: CK Group
Contact Detail:
CK Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person
✨Tip Number 1
Familiarise yourself with the latest GMP guidelines and EC directives relevant to the role of a Qualified Person. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who are already working as Qualified Persons. Engaging in conversations can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your ability to conduct audits and mentor staff. Real-life scenarios can make a strong impression during interviews.
✨Tip Number 4
Research the company’s recent projects and initiatives in Quality Assurance. Being knowledgeable about their operations can help you tailor your responses and show genuine interest during the interview process.
We think you need these skills to ace Qualified Person
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Qualified Person as outlined in the job description. Familiarise yourself with the legal duties and quality assurance activities required.
Tailor Your CV: Highlight your QP qualification and relevant experience in Quality Assurance, especially with oral solid dose or sterile products. Make sure to include specific examples that demonstrate your knowledge of GMP guidelines and your ability to conduct audits.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention how your background aligns with the responsibilities listed, such as your experience in training and mentoring staff in GMP compliance.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that all information is accurate and that you have quoted the job reference 143532 as requested.
How to prepare for a job interview at CK Group
✨Know Your Regulations
Familiarise yourself with the EC directive 2001/83/EC and 2001/20/EC, as well as the UK Code of Practice for Qualified Persons. Being able to discuss these regulations confidently will demonstrate your expertise and understanding of the legal duties required in the role.
✨Showcase Your Experience
Prepare to discuss your previous experience with oral solid dose or sterile products. Highlight specific examples where you successfully implemented Quality Assurance activities or managed compliance with GMP guidelines, as this will show your practical knowledge in the field.
✨Emphasise Communication Skills
Since the role requires effective communication within the manufacturing unit and with external partners, be ready to provide examples of how you've established strong working relationships in past roles. This could include mentoring staff or collaborating on audits.
✨Prepare for Technical Questions
Expect to be asked about your ability to interpret complex data and conduct audits. Brush up on your technical knowledge and be prepared to discuss how you've approached these tasks in previous positions, including any challenges you faced and how you overcame them.