Contract Qualified Person

4 days ago

Leeds, Leeds, United Kingdom MAC Clinical Research Full time
Job Description

About MAC Clinical Research

MAC Clinical Research is a leading Contract Research Organisation (CRO) providing comprehensive services to the pharmaceutical industry. Our mission is to deliver high-quality research solutions with integrity and honesty, making a significant contribution to human health.

We are seeking a highly skilled Qualified Person to join our team and contribute to our mission. As a Qualified Person, you will play a critical role in ensuring the quality and safety of investigational medicinal products (IMPs) in clinical trials.

Key Responsibilities
  • Certification of IMPs under the MIA IMP licence, in accordance with 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 IMPs for use in human clinical trials at MAC Clinical Research facilities, ensuring subject safety, in accordance with 2001/20/EC Article 9
  • Ensuring compliance with MIA IMP
  • Working with and organising the workload of any other contract/trainee QPs employed by MAC
  • Review and approval of Technical Quality Agreements
  • Review and approval of Master Batch Records
  • Review of Clinical Trial Agreements (CTAs)
  • Review of IMP labels, in accordance with Annex 13
  • Review and approval of Pharmaceutical Specifications and Formulations (PSFs)
  • Review and approval of executed Batch Records
  • Checking and signing QP Certification documents for each batch
  • Recording batch certification and release in the QP Batch register
  • Acting upon product complaints, deviations, and recalls
  • Ensuring that the Quality Management System is robust and effectively implemented to support safe IMP manufacture and release
  • Oversight of the management and maintenance of Good Manufacturing Practice (GMP) compliance
  • Performing GMP audits to monitor compliance
  • Conducting audits of third-party GMP providers, as required
  • Attending regulatory inspections and GMP sponsor audits, as required
  • Performing GMP training to staff, as required
  • Interpreting, communicating, and ensuring that new regulations are incorporated into procedures
  • Involvement with incidents, deviations, and corrective action plans (CAPAs), as required
  • Undertaking Continuing Professional Development, as required
  • Following the Qualified Person Code of Practice
  • Maintaining personal training and attending training sessions, as required
  • Compliance with MAC Clinical Research's health and safety policy
  • Compliance with MAC Clinical Research's policy on equality and diversity
  • Maintaining professional qualifications required for the role, including continuous personal development
  • Working to the requirements of SI 2004 No. 1031 and amendments thereof, which includes Good Clinical Practice
  • Working according to MAC Clinical Research SOPs, guidelines, and policies
  • Working according to current data protection standards and practicing good information management, maintaining strict confidentiality of patient and business-related data
  • Maintaining a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure job role efficiency
  • Supporting the aims of MAC Clinical Research and representing the company professionally to all customers
Physical Work Environment and Travel Demands

As a Qualified Person, you may be required to work at other MAC Clinical Research sites or remotely. Travel between sites will be necessary for this role and to participate in inter-site meetings or problem-solving groups.

Benefits
  • Competitive salary in line with pharmaceutical industry standards, reflecting experience
  • Health insurance
  • Free onsite parking
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service)
  • Your birthday off work

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