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- Tasks: Join our team as a Qualified Person, certifying IMP for clinical trials.
- Company: MAC is a global CRO dedicated to improving human health with integrity.
- Benefits: Enjoy competitive salary, health insurance, 25 days leave, and your birthday off!
- Why this job: Make a positive impact in a supportive environment focused on your growth.
- Qualifications: Pharmacy or science degree, 2+ years in clinical trials, and QP eligibility required.
- Other info: Flexible working options available, with some remote work and travel between sites.
The predicted salary is between 36000 - 60000 £ per year.
MAC is a full-service global Contract Research Organisation (CRO) with a mission to serve with honesty and integrity to make an outstanding contribution to human health. We are seeking to appoint a Qualified Person to join our team and make a positive impact in a growing and progressive CRO. This is a fantastic opportunity to work with an experienced QA and Production team in an inclusive company that puts the needs and wellbeing of their people first, delivering exceptional service.
The focus of the job is the certification of IMP under our MIA IMP licence under directive 2001/20/EC Article 13. You will be working primarily from our Leeds site, with regular visits to our Manchester site. You will be expected to attend at site if required, but with some remote working as appropriate. Some flexibility will be necessary, and out-of-hours working will also apply, on a pre-arranged basis.
KEY SKILLS AND 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
Responsibilities:
- Certification of IMP under MIA IMP licence under directive 2001/20/EC Article 13
- Performing the duties of the Qualified Person(s) as described in Article 51 of Directive 2001/83/EC and the applicable UK Statutory Instrument
- Release of IMP for use in human Clinical Trials at MAC Clinical Research facilities according to 2001/20/EC article 9 to ensure subject safety
- Ensure compliance with MIA IMP
- Working with and organising workload of any other contract/trainee QPs employed by MAC
- Review and approve Technical Quality Agreements, Batch Records, CTA, PSF and IMP label according to Annex 13
- 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
- Oversight of the management and maintenance of GMP compliance, performing GMP audits to monitor compliance, attend regulatory Inspections and GMP Sponsor audits as required
- Perform GMP training to staff as required
- Interpret, communicate, and ensure that new regulations are incorporated into procedures
- Work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice
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
- 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 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 (QP) employer: MAC Clinical Research
Contact Detail:
MAC Clinical Research Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person (QP)
✨Tip Number 1
Familiarise yourself with the specific regulations and directives mentioned in the job description, such as the MIA IMP licence and Article 13 of directive 2001/20/EC. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance and safety in clinical trials.
✨Tip Number 2
Network with professionals in the pharmaceutical and CRO sectors, especially those who are already working as Qualified Persons. Engaging with them can provide insights into the role and may even lead to referrals or recommendations for the position at MAC.
✨Tip Number 3
Prepare to discuss your experience in clinical trials and how it relates to the responsibilities outlined in the job description. Be ready to share specific examples of your work in GMP compliance, audits, and training, as these are crucial aspects of the QP role.
✨Tip Number 4
Show your enthusiasm for the company's mission and values during your interactions. MAC Clinical Research prioritises integrity and the wellbeing of its employees, so expressing your alignment with these values can set you apart from other candidates.
We think you need these skills to ace Qualified Person (QP)
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Qualified Person position. Understand the key responsibilities and qualifications required, such as the need for a Pharmacy, Biological or Chemical Science degree and experience in Clinical Trials.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the requirements of the role. Emphasise your qualifications, particularly any experience you have in CROs or clinical trials, and ensure to mention your eligibility to act as a QP.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Discuss how your background and experiences make you a suitable candidate for the Qualified Person position, and express your enthusiasm for contributing to MAC's mission of improving human health.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects attention to detail, which is crucial in the pharmaceutical industry.
How to prepare for a job interview at MAC Clinical Research
✨Know Your Regulations
Familiarise yourself with the relevant regulations, particularly Directive 2001/20/EC and Article 51 of Directive 2001/83/EC. Being able to discuss these in detail will demonstrate your expertise and readiness for the role.
✨Highlight Your Experience
Prepare to discuss your previous experience in clinical trials and how it relates to the responsibilities of a Qualified Person. Specific examples of your work in a CRO or Phase 1 Unit will be particularly valuable.
✨Showcase Your Teamwork Skills
Since you'll be working closely with QA and Production teams, emphasise your ability to collaborate effectively. Share examples of how you've successfully worked in teams to achieve common goals.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's culture, the team you'll be working with, and their approach to compliance and quality management. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
