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 aQualified Personto 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 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
Interpret, communicate, and ensure that new regulations are incorporated into procedures
To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice
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
Cycle to work scheme
Eye care vouchers
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 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.
