Lead Qualified Person

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. We are seeking to appoint a Qualified Person to join our team and make a positive impact in a growing and progressive CRO. You will be expected to attend at site if required, but with some remote working, as appropriate. 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 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 Working with and organising workload of any other contract/trainee QPs employed by MAC Review and approve Technical Quality Agreements, Batch Records, CTA, PSF and IMP label according to Annex 13 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, performing GMP audits to monitor compliance, attend regulatory Inspections and GMP Sponsor audits as required Perform GMP training to staff as required 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. 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