MAC Clinical Research | QP - LeedsPLACEHOLDEREngland
MAC Clinical Research | QP - LeedsPLACEHOLDEREngland

MAC Clinical Research | QP - LeedsPLACEHOLDEREngland

Leeds Full-Time 36000 - 60000 £ / year (est.) No home office possible
M

At a Glance

  • 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 with 2+ years in clinical trials required.
  • Other info: Flexible working options available, including 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). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding. 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 put the needs and wellbeing of their people first, and who deliver 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 Review and approve Master Batch Records Review CTA Review IMP label according to Annex 13 Review and approve PSF Review and approve executed Batch Records Check and sign QP Certification document for each batch Record batch certification and release 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 Oversight of the management and maintenance of GMP compliance Perform GMP audits to monitor compliance Conduct audits of third party GMP providers as required 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 Involvement with Incidents, Deviations and CAPAs as required Undertake Continuing Professional Development as required 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 maintain professional qualifications required for the role, including continuous personal development To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice 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 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 maccareers@macplc.com 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.

MAC Clinical Research | QP - LeedsPLACEHOLDEREngland employer: MAC Clinical Research

At MAC Clinical Research, we pride ourselves on being an exceptional employer that prioritizes the wellbeing and professional growth of our team members. Located in Leeds, with additional opportunities for collaboration at our Manchester site, we offer a supportive work culture that values integrity and inclusivity. Our competitive benefits package, including health insurance, generous annual leave, and a commitment to your career development, makes MAC an ideal place for Qualified Persons looking to make a meaningful impact in the pharmaceutical industry.
M

Contact Detail:

MAC Clinical Research Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land MAC Clinical Research | QP - LeedsPLACEHOLDEREngland

✨Tip Number 1

Familiarize yourself with the specific regulations and directives mentioned in the job description, such as the MIA IMP licence and Directive 2001/20/EC. Understanding these will not only help you in interviews but also demonstrate your commitment to compliance and safety.

✨Tip Number 2

Network with professionals in the Clinical Research field, especially those who have experience as a Qualified Person. Engaging with them can provide insights into the role and may even lead to referrals or recommendations.

✨Tip Number 3

Highlight any relevant experience you have in GMP compliance and audits during your conversations with us. This is crucial for the role, and showcasing your expertise can set you apart from other candidates.

✨Tip Number 4

Be prepared to discuss your approach to continuous professional development. We value candidates who are proactive about their learning and growth, so share any relevant training or certifications you've pursued.

We think you need these skills to ace MAC Clinical Research | QP - LeedsPLACEHOLDEREngland

Pharmacy Degree
Biological Science Degree
Chemical Science Degree
Membership in a Recognised Professional Body
Experience in Clinical Trials
Knowledge of MIA IMP Licence
Understanding of Directive 2001/20/EC
Quality Assurance Skills
GMP Compliance Knowledge
Technical Quality Agreement Review
Master Batch Record Approval
Clinical Trial Application Review
IMP Label Review
Batch Record Review and Approval
QP Certification Documentation
Incident and Deviation Management
CAPA Involvement
Regulatory Inspection Preparation
Audit Skills for GMP Compliance
Training and Development Skills
Strong Communication Skills
Attention to Detail
Ability to Work Flexibly
Team Collaboration

Some tips for your application 🫡

Understand the Role: Make sure to thoroughly read the job description for the Qualified Person position at MAC Clinical Research. Understand the key responsibilities and qualifications required, as this will help you tailor your application.

Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in clinical trials within the pharmaceutical industry, particularly any roles related to CROs or hospital pharmacy. Mention specific projects or responsibilities that align with the job requirements.

Showcase Your Qualifications: Clearly state your educational background, including your Pharmacy, Biological, or Chemical Science degree. Also, mention your membership in recognized professional bodies, as this is a key requirement for the role.

Personalize Your Application: Craft a personalized cover letter that reflects your passion for contributing to human health and your alignment with MAC's mission. Discuss how your values match those of the company and why you want to be part of their team.

How to prepare for a job interview at MAC Clinical Research

✨Understand the Role of a Qualified Person

Make sure you have a clear understanding of the responsibilities and expectations of a Qualified Person in a CRO. Familiarize yourself with the relevant regulations, such as the MIA IMP licence and the directives mentioned in the job description.

✨Showcase Your Experience

Prepare to discuss your previous experience in clinical trials and how it relates to the role. Highlight specific examples where you ensured compliance, managed quality systems, or conducted audits, as these will be crucial to your success in the interview.

✨Demonstrate Your Commitment to Continuous Development

Since the role requires ongoing professional development, be ready to talk about how you stay updated with industry changes and regulations. Mention any relevant training or certifications you have pursued recently.

✨Emphasize Teamwork and Communication Skills

As the position involves working with various teams and stakeholders, illustrate your ability to collaborate effectively. Share examples of how you've communicated complex information clearly and worked well within a team setting.

MAC Clinical Research | QP - LeedsPLACEHOLDEREngland
MAC Clinical Research
M
  • MAC Clinical Research | QP - LeedsPLACEHOLDEREngland

    Leeds
    Full-Time
    36000 - 60000 £ / year (est.)

    Application deadline: 2027-01-22

  • M

    MAC Clinical Research

Similar positions in other companies
Europas größte Jobbörse für Gen-Z
discover-jobs-cta
Discover now
>