Radiopharmaceutical QP in City of Westminster

Radiopharmaceutical QP in City of Westminster

City of Westminster Full-Time 54000 - 126000 £ / year (est.) No working from home possible
ARx Recruitment Services

At a Glance

  • 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, with opportunities for professional growth and development.
  • Other info: Ideal for those passionate about compliance and quality in the pharmaceutical industry.
  • Why this job: Be part of a mission-driven team making a real impact in healthcare and patient outcomes.
  • Qualifications: Must have a Master's in Pharmacy or Life Sciences and extensive experience in pharmaceutical quality.

The predicted salary is between 54000 - 126000 £ 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 of 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 * 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 City of Westminster employer: ARx Recruitment Services

At CMDO, we pride ourselves on being an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration in the pharmaceutical sector. Our commitment to employee growth is evident through comprehensive training programmes and opportunities for advancement, all while working in a state-of-the-art facility located in a vibrant area that supports both professional and personal development. Join us to be part of a team dedicated to making a meaningful impact in the field of medicine, where your expertise as a Qualified Person will be valued and rewarded.

ARx Recruitment Services

Contact Details:

ARx Recruitment Services Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Radiopharmaceutical QP in City of Westminster

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

Familiarise yourself with the specific regulations and guidelines mentioned in the job description, such as Eudralex Volume 4 and Human Medicines Regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance.

Tip Number 3

Consider reaching out to current or former employees of CMDO to gain insights into the company culture and expectations for the role. This can provide you with valuable information that can be used during discussions.

Tip Number 4

Prepare to discuss your managerial experience and how it relates to ensuring compliance during regulatory inspections. Be ready to share specific examples of how you've successfully managed teams and projects in a pharmaceutical setting.

We think you need these skills to ace Radiopharmaceutical QP in City of Westminster

Qualified Person (QP) Certification
Knowledge of EC Directive 2001/20/EC
Understanding of Human Medicines Regulations 2012
Batch Certification and Release Functions
Pharmaceutical Quality Management System
Pharmaceutical Quality Control Service
GMP Validation

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:In your cover letter, express your passion for the role of Qualified Person and how your background aligns with CMDO's mission. Mention your extensive knowledge of regulations such as 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 eligibility under the relevant statutory instruments and your practical knowledge of pharmaceutical manufacturing.

Showcase Problem-Solving Skills:Provide examples of how you've successfully managed deviations and out-of-specification results in previous roles. Highlight your ability to perform root cause analysis and develop effective CAPAs, as these are crucial for the position.

How to prepare for a job interview at ARx Recruitment Services

Know Your Regulations

Familiarise yourself with the EC Directive 2001/20/EC and Human Medicines Regulations 2012. Be prepared to discuss how your experience aligns with these regulations, especially in relation to QP duties and compliance.

Showcase Your Technical Expertise

Highlight your extensive knowledge in GMP validation, batch certification, and the manufacturing of sterile injectable products. Be ready to provide specific examples from your past roles that demonstrate your expertise in these areas.

Demonstrate Leadership Skills

Since managerial experience is crucial for this role, prepare to discuss your leadership style and how you've successfully managed teams in a pharmaceutical setting. Share instances where you’ve led training or development initiatives.

Prepare for Scenario-Based Questions

Expect questions that assess your problem-solving skills, such as how you would handle deviations or out-of-specification results. Think of real-life scenarios where you applied risk assessment and root cause analysis effectively.