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- Tasks: Certify investigational medicinal products for clinical trials and ensure compliance with regulations.
- Company: Join a progressive CRO that values your growth and impact.
- Benefits: Competitive salary, health insurance, 25 days leave, and your birthday off!
- Other info: Dynamic role with travel opportunities and a supportive team environment.
- Why this job: Make a real difference in clinical research while advancing your career.
- Qualifications: Degree in Pharmacy or related field and experience in clinical trials.
The predicted salary is between 40000 - 50000 £ per year.
We are seeking to appoint a Qualified Person to join our team and make a positive impact in a growing and progressive CRO. The role will be based at either Leeds or Manchester with the expectation to travel between sites when required. The focus of the job is the certification of IMP under our MIA IMP licence under directive 2001/20/EC Article 13. To ensure all MAC Research sites comply with regulations of GCP and GMP regarding drug receipt, dispensing/preparation, storage and return of IMP/commercial and comparator.
RESPONSIBILITIES
- Release of IMP for use in human Clinical Trials at MAC Clinical Research
- Ensure compliance with MIA IMP
- Review and approve Technical Quality Agreements, Master Batch Records, Annex 13, Production and Pharmacy Manuals, and other applicable study documentation
- Review CTA, Annex 13 labels, IMPD, and other applicable submission documents for compliance
- Maintenance of the Product Specification File, and Pharmacy Files for studies under role lead
- Review and approve executed Batch Records, signed QP Certification for each batch, record batch certification and release, as application, in QP batch register
- Act upon product complaints, deviations and recalls
- Ensure that the Quality Management System is robust and effectively implemented to support safe IMP manufacture and release
- Maintain professional qualifications required for the role, including continuous professional development
- Follow QP code of Practice
- Maintain Personal training and attend training sessions as required
- Compliance with MAC health and Safety policy
- Compliance with MAC policy on equality and diversity
- To work according to MAC SOPs, guidelines and policies
- To work according to current data protection standards and practice good information management
- Maintenance of strict confidentiality of patient and business-related data
- To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out
- To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers
- To all items included in Job Description for Clinical Trials Pharmacist
- Any other Quality or Pharmacy tasks required.
Qualifications
- Pharmacy, Biological or Chemical Science degree
- Member of recognised professional body (Royal Pharmaceutical Society GB, Royal Society of Chemistry, or Institute of Biology)
- Two or more years’ experience of Clinical Trials within the Pharmaceutical industry
- Experience in CRO, Phase 1 Unit or Hospital pharmacy
- Eligibility to act as QP and be named on MIA IMP Licence
- Eligibility to act as a Clinical Trials Pharmacist is preferred, but not essential
Physical Work Environment and Travel Demands
QP activities may be carried out at other MAC sites or remotely, so travel between sites will be necessary for this role and to participate in inter-site meetings or problem-solving groups.
BENEFITS:
- Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
- Health Insurance
- Eye Care Vouchers
- Cycle to work scheme
- Free onsite parking
- 25 days annual leave (increasing in increments to 30 days after 6 years' service)
- Your birthday off work
MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations. Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.
Qualified Person - Clinical Trials Pharmacist in Leeds employer: MAC Clinical Research
Contact Detail:
MAC Clinical Research Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person - Clinical Trials Pharmacist in Leeds
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in CROs or clinical trials. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP and GMP regulations. We want you to shine when discussing how you can ensure compliance with MIA IMP and other relevant guidelines during your interview.
✨Tip Number 3
Don’t forget to showcase your continuous professional development! Highlight any recent training or certifications that relate to the role of a Qualified Person. This shows us you're committed to staying at the top of your game.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it gives you a chance to explore more about MAC Clinical Research and what we stand for before you hit that submit button.
We think you need these skills to ace Qualified Person - Clinical Trials Pharmacist in Leeds
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Qualified Person. Highlight your experience in clinical trials and any relevant qualifications that match the job description. We want to see how your background aligns 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 this role and how you can contribute to our team. Be sure to mention your understanding of GCP and GMP regulations, as these are key to the position.
Showcase Your Professional Development: Don’t forget to mention any continuous professional development you've undertaken. We value candidates who are committed to staying updated in their field, so let us know how you keep your skills sharp!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at MAC Clinical Research
✨Know Your Regulations
Familiarise yourself with the MIA IMP licence and the relevant regulations like GCP and GMP. Being able to discuss these in detail will show your expertise and commitment to compliance, which is crucial for the role.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in clinical trials and pharmacy. Discuss any challenges you faced and how you overcame them, especially in relation to IMP certification and quality management.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to clinical trials and their quality management systems. This not only shows your interest but also helps you gauge if the company aligns with your professional values.
✨Demonstrate Continuous Learning
Highlight your commitment to professional development by discussing any recent training or certifications you've pursued. This is particularly important in a field that evolves rapidly, and it shows you're proactive about staying current.