Qualified Person

6 days ago

Leeds, Leeds, United Kingdom MAC Clinical Research Full time
About MAC Clinical Research

MAC Clinical Research is a global Contract Research Organisation (CRO) that provides 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.

Job Summary

We are seeking a highly skilled Qualified Person to join our team at MAC Clinical Research. As a Qualified Person, you will play a critical role in ensuring the quality and safety of medicinal products.

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 Investigational Medicinal Products (IMPs) for use in human clinical trials at MAC Clinical Research facilities, ensuring subject safety.
  • Work with and organize the 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.
  • Comply with MAC's health and safety policy.
  • Comply with MAC's policy on equality and diversity.
  • Maintain professional qualifications required for the role, including continuous personal development.
  • Work according to MAC SOPs, guidelines, and policies.
  • Work according to current data protection standards and practice good information management.
  • Maintain strict confidentiality of patient and business-related data.
Requirements
  • Pharmacy, Biological, or Chemical Science degree.
  • Member of a recognized 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.
  • 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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