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 MAC

Review 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.