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- Tasks: Join us as a Qualified Person, ensuring compliance and quality in pharmaceutical manufacturing.
- Company: CMDO is at the forefront of developing innovative medicines and formulations for clinical trials.
- Benefits: Enjoy a competitive salary of £90K and opportunities for professional growth.
- Why this job: Be part of a mission-driven team making a real impact in healthcare and pharmaceuticals.
- Qualifications: Must have a Master's degree in Pharmacy or related fields and extensive experience in batch certification.
- Other info: Ideal for those passionate about quality assurance in the pharmaceutical industry.
The predicted salary is between 72000 - 108000 £ per year.
CMDO is seeking to appoint a Qualified Person. The organisation is engaged in developing and manufacturing new medicines and novel formulations, including a wide range of oral solid and liquid dosage forms, sterilised and aseptically filled products, as well as manufacturing and QP certification of a range of Phase I/II clinical trials for the UK and EU markets.
ROLE
- Perform the legal duties of a Qualified Person (QP) on the MIA(IMP) as specified under EC Directive 2001/20/EC and Human Medicines Regulations 2012.
- Ensure compliance with the requirements of Eudralex Volume 4, Part 1, Annexes 13 and 16.
- Undertake QP batch certification and release functions within departments named on the relevant site manufacturers authorisation (IMP).
- Responsible for all QP activities and associated resource planning, training, development and management.
- Ensuring the completeness and effectiveness of the pharmaceutical quality management system and pharmaceutical quality control service as per the requirements for the Qualified Person, described in Human Medicines Regulations 2012 and EudraLex Volume 4, Part 1, Annex 13 and Annex 16.
REQUIRED
- Masters degree in Pharmacy, Biochemistry, Chemistry, or Life Sciences.
- Extensive specialist knowledge and experience of batch certification/release of sterile injectable manufacture, manufacture of specials (unlicensed) medicinal products, investigational medicinal products for clinical trials and radiopharmaceuticals.
- Eligibility to function as an EU QP for investigational medicinal products under Statutory Instrument 2004:1031.
- Eligibility to function as an EU QP under the permanent provisions for medicinal products under Statutory Instrument 2012:1916.
- Extensive experience in GMP validation of pharmaceutical facilities, utilities, equipment, processes and analytical methods.
- Managerial experience in a pharmaceutical organisation and a track record of compliance at regulatory inspections.
- Experience of research and supply of IMP medicines for clinical trials.
- Expert knowledge of GCP, GMDP, quality systems and pharmaceutical analysis.
- Expert knowledge of pharmaceutical microbiology and quality control.
- Expert practical knowledge of GCP, GMDP, QA and all current relevant regulations.
- Expert technical knowledge of pharmaceutical sterile and non-sterile manufacturing.
- Demonstrable ability to risk assess, perform root cause analysis and resolve deviations and out of specification results and develop suitable CAPAs.
- Demonstrable ability to ensure quality through set-up, manufacturing and release of IMPs under a MAIMP to comply fully with the requirements of GMP and GCP.
REMUNERATION £90K, subject to qualifications and experience.
Radiopharmaceutical QP employer: ARx Recruitment Services
Contact Detail:
ARx Recruitment Services Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Radiopharmaceutical QP
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience as Qualified Persons. Attend relevant conferences or seminars to meet potential colleagues and learn about the latest trends in radiopharmaceuticals.
✨Tip Number 2
Join online forums or groups focused on pharmaceutical quality management and regulatory compliance. Engaging in discussions can help you gain insights and make connections that could lead to job opportunities.
✨Tip Number 3
Consider reaching out directly to CMDO or similar organisations to express your interest in the role. A proactive approach can set you apart from other candidates and demonstrate your enthusiasm for the position.
✨Tip Number 4
Stay updated on the latest regulations and guidelines related to GMP and GCP. Being knowledgeable about current standards will not only prepare you for the role but also show potential employers that you are committed to maintaining high-quality practices.
We think you need these skills to ace Radiopharmaceutical QP
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant qualifications and experiences, particularly in areas like batch certification, GMP validation, and your managerial experience in a pharmaceutical organisation. Use specific examples to demonstrate your expertise.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your passion for the role of Qualified Person and how your background aligns with the responsibilities listed in the job description. Mention your understanding of Eudralex Volume 4 and your experience with clinical trials.
Highlight Relevant Qualifications: Clearly state your Master's degree and any additional certifications that qualify you as an EU QP. Emphasise your extensive knowledge of pharmaceutical regulations and quality systems, as these are crucial for the role.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is accurate and clearly presented. A polished application reflects your attention to detail.
How to prepare for a job interview at ARx Recruitment Services
✨Showcase Your Expertise
Make sure to highlight your extensive knowledge and experience in batch certification and release of sterile injectable manufacture. Be prepared to discuss specific examples from your past roles that demonstrate your understanding of the relevant regulations and compliance standards.
✨Understand the Regulatory Landscape
Familiarise yourself with Eudralex Volume 4, Part 1, Annexes 13 and 16, as well as the Human Medicines Regulations 2012. During the interview, you might be asked about how these regulations impact your work as a Qualified Person, so having a solid grasp of them will show your preparedness.
✨Demonstrate Leadership Skills
Since managerial experience is crucial for this role, be ready to discuss your leadership style and how you've successfully managed teams in the past. Share examples of how you've developed and trained staff, ensuring compliance and quality within your team.
✨Prepare for Technical Questions
Expect technical questions related to GMP validation, pharmaceutical microbiology, and quality control. Brush up on your knowledge in these areas and be ready to explain complex concepts clearly, showcasing your expert technical knowledge.
