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. This is a fantastic opportunity to work with an experienced QA and Production team in an inclusive company that put the needs and wellbeing of their people first, and who deliver exceptional service. The focus of the job is the certification of IMP under our MIA IMP licence under directive 2001/20/EC Article 13. You will be working primarily from our Leeds site, with regular visits to our Manchester site. You will be expected to attend at site if required, but with some remote working, as appropriate. Some flexibility will be necessary, and out-of-hours working will also apply, on a pre-arranged basis. KEY SKILLS AND QUALIFICATIONS: 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 Eligibility to act as QP and be named on MIA IMP Licence Responsibilities: Certification of IMP under MIA IMP licence under 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 IMP for use in human Clinical Trials at MAC Clinical Research facilities according to 2001/20/EC article 9 to ensure subject safety Ensure compliance with MIA IMP Working with and organising workload of any other contract/trainee QPs employed by MACReview and approve Technical Quality Agreements Review and approve Master Batch Records Review CTA Review IMP label according to Annex 13 Review and approve PSF Review and approve executed Batch Records Check and sign QP Certification document for each batch Record batch certification and release in QP Batch register 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 Perform GMP audits to monitor compliance Conduct audits of third party GMP providers as required Attend regulatory Inspections and GMP Sponsor audits as required Perform GMP training to staff as required Interpret, communicate, and ensure that new regulations are incorporated into procedures Involvement with Incidents, Deviations and CAPAs as required Undertake Continuing Professional Development as required Follow QP code of Practice 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 to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice 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. To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out To support the aims of MAC and to represent 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 MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations. Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.