Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Ensure compliance and perform QP duties for innovative medicines and clinical trials.
- Company: Leading CMDO focused on developing new medicines and formulations.
- Benefits: Competitive salary of £90K, plus opportunities for professional growth.
- Other info: Exciting role with a focus on quality and regulatory compliance.
- Why this job: Join a dynamic team making a real impact in the pharmaceutical industry.
- Qualifications: Masters in Pharmacy or Life Sciences with extensive QP experience.
The predicted salary is between 90000 - 90000 £ 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 like a pro! Reach out to professionals in the pharmaceutical industry, especially those who work with radiopharmaceuticals. Attend relevant events or webinars and don’t be shy about introducing yourself – you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP, GCP, and the specific regulations mentioned in the job description. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to get comfortable with common questions related to QP responsibilities. This will help you articulate your experience and skills effectively when it counts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are ready to make an impact in the pharmaceutical field.
We think you need these skills to ace Radiopharmaceutical QP
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of a Qualified Person. Highlight your relevant experience in batch certification and your knowledge of GMP regulations. We want to see how your background fits with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about radiopharmaceuticals and how your skills align with our needs. Keep it concise but impactful – we love a good story!
Showcase Your Qualifications: Don’t forget to mention your Masters degree and any certifications that make you eligible to function as an EU QP. We’re keen on seeing your academic achievements and how they relate to the role.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at ARx Recruitment Services
✨Know Your Regulations
Familiarise yourself with the key regulations and guidelines mentioned in the job description, such as Eudralex Volume 4 and Human Medicines Regulations. Being able to discuss these confidently will show that you’re not just qualified on paper but also understand the practical implications of these regulations.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in batch certification and compliance during regulatory inspections. Use the STAR method (Situation, Task, Action, Result) to structure your responses, making it easier for the interviewer to see your impact.
✨Demonstrate Leadership Skills
Since managerial experience is crucial for this role, be ready to discuss how you've led teams or projects in the past. Highlight any training or development initiatives you've implemented, as well as how you’ve managed resources effectively to ensure compliance and quality.
✨Prepare Questions
Think of insightful questions to ask at the end of the interview. This could include inquiries about the company’s approach to GMP validation or how they handle deviations in production. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.