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Qualified Person

2 months ago

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

Job Title: Qualified Person - Clinical Trials Specialist

Company: MAC Clinical Research

Job Type: Full-time

Location: Remote (with occasional site visits)

About Us: MAC Clinical Research is a global Contract Research Organisation (CRO) that provides comprehensive services to the pharmaceutical industry. We are committed to delivering high-quality results while ensuring the safety and well-being of our clients and their patients.

Job Summary

We are seeking a highly skilled and experienced Qualified Person to join our team. The successful candidate will be responsible for ensuring the quality and compliance of our clinical trials, while also providing guidance and support to our staff.

Key Responsibilities:
  • Perform the duties of the Qualified Person 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.
  • Working with and organising workload of any other contract/trainee QPs employed by MAC.
  • Review and approve Technical Quality Agreements.
  • 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.
  • Attend regulatory Inspections and GMP Sponsor audits as required.
  • Perform GMP training to staff as required.
  • Undertake Continuing Professional Development as required.
  • 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 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.
Requirements:
  • 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.
What We Offer:
  • 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.