QUALIFIED PERSON QP (IMP)
Closing date for applications: 31 March 2021
Does the idea of working for a growing company and being fundamental to that growth excite you?
Are you interested in the opportunity to make a difference in the world of research?
If the answer to the above questions is YES then read on – this may be the new and exciting role you’ve been looking for!
MAC is one of the UK's most successful Clinical Development Organisations and we conduct and execute clinical trials in various therapeutic areas.
We are seeking to appoint an experienced Qualified Person QP (IMP) to work with our dedicated Pharmacy Team in Manchester (and Leeds - this is flexible and can be discussed).
Certification of IMP Under MIA IMP licence under directive 2001/20/EC Article 13
Release of IMP for use in human Clinical Trials
Facilitate according to 2001/20/EC article 9 to ensure subject safety
Ensure compliance with MIA IMP
Review and approve Technical Quality Agreements, Master Batch Records, PSF and executed Batch Records
Review CTA and IMP label according to annex 13
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 Systems is robust and effectively implemented to support safe IMP manufacture and release
Perform GMP audits to monitor compliance
Conduct audits of third party GMP providers as required
Attend regulatory inspections and SMP 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
Follow QP code of practice
QUALIFICATIONS AND SKILLS:
Pharmacy, Biological or Chemical Science degree
Member of recognised professional body (Royal Pharmaceutical Society GB, Royal Society of Chemistry, Institute of Biology)
2 years + experience of Clinical Trials within the Pharmaceutical Industry
Experience in CRO, Phase 1 or Hospital Pharmacy
Eligibility to be named on MIA IMO Licence
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave + bank holidays (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 achieve 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 note that if we receive a high volume of applications this date may be brought forwards.
Salary: Excellent + Negotiable £ Apply Now