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- Tasks: Ensure compliance and certification of innovative medicines and clinical trials.
- Company: Leading organisation in developing new medicines and formulations.
- Benefits: Competitive salary, professional development, and a chance to impact healthcare.
- Other info: Exciting opportunity for career growth in a fast-paced environment.
- Why this job: Join a dynamic team making a difference in the pharmaceutical industry.
- Qualifications: Master's degree in relevant sciences and extensive experience in pharmaceutical quality.
The predicted salary is between 54000 - 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.
Responsibilities
- 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.
Requirements
- 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.
- Demonstratable 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 in Westminster employer: ARx Recruitment Services
Contact Detail:
ARx Recruitment Services Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Radiopharmaceutical QP in Westminster
✨Tip Number 1
Network like a pro! Reach out to professionals in the radiopharmaceutical field on LinkedIn or at industry events. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP, GCP, and the latest regulations. We recommend doing mock interviews with friends or mentors to get comfortable discussing your expertise and experiences.
✨Tip Number 3
Showcase your skills through real-life examples. When discussing your experience with batch certification or quality control, use specific instances where you made an impact. We want to see how you’ve tackled challenges in the past!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Radiopharmaceutical QP in Westminster
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Radiopharmaceutical QP. Highlight your relevant experience in batch certification and compliance with GMP regulations, as these are key for us.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this position. Share specific examples of your experience with sterile injectable manufacture and how you’ve ensured compliance in previous roles.
Showcase Your Qualifications: Don’t forget to mention your Masters Degree and any relevant certifications. We want to see that you meet the eligibility criteria to function as an EU QP, so make it clear!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role without any hiccups!
How to prepare for a job interview at ARx Recruitment Services
✨Know Your Regulations
Familiarise yourself with the key regulations and guidelines relevant to the role, such as Eudralex Volume 4 and Human Medicines Regulations. Being able to discuss these confidently will show your expertise and commitment to compliance.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in batch certification and GMP validation. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Demonstrate Leadership Skills
Since managerial experience is crucial, be ready to discuss how you've led teams or projects in a pharmaceutical setting. Highlight your ability to train and develop others, as well as how you’ve managed compliance during inspections.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s current projects or challenges in the radiopharmaceutical field. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.