QUALIFIED PERSON QP (IMP)

Closing date for applications:  31 October 2020

                                                                                                                                                                        

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).

 

KEY RESPONSIBILITIES:

  • 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

                                                                                                                                                         

BENEFITS:

  • 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.

View the Job Description

Salary: Excellent + Negotiable £                                                                  Apply  Now                                                                                                                                                               

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