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Qualified Person

2 months ago

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

About the Role

We are seeking a highly skilled and experienced Qualified Person to join our team at MAC Clinical Research. As a key member of our QA and Production team, you will play a critical role in ensuring the quality and safety of our clinical trials.

Key Responsibilities

  • Certification of Investigational Medicinal Products (IMPs) under our MIA IMP licence
  • 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 compliance with MIA IMP and Good Clinical Practice (GCP)
  • Working with and organizing the workload of any other contract/trainee QPs employed by MAC
  • Reviewing and approving Technical Quality Agreements, Master Batch Records, and other critical documents
  • Acting upon product complaints, deviations, and recalls
  • Ensuring 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
  • 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 CAPAs as required
  • Undertaking Continuing Professional Development as required
  • Following the QP code of practice
  • Maintaining personal training and attending training sessions as required
  • Compliance with MAC health and safety policy
  • Compliance with MAC 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 SOPs, guidelines, and policies
  • Working according to current data protection standards and practicing good information management
  • Maintenance of 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 your job role is efficiently carried out
  • Supporting the aims of MAC and representing 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