Qualified Person

7 days ago

Leeds, Leeds, United Kingdom MAC Clinical Research Full time

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 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

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 maccareers@macplc.com 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.

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