Qualified Person in Leeds

We are seeking to appoint a Qualified Person to join our team and make a positive impact in a growing and progressive CRO. The role will be based at either Leeds or Manchester with the expectation to travel between sites when required. The focus of the job is the certification of IMP under our MIA IMP licence under directive 2001/20/EC Article 13. To ensure all MAC Research sites comply with regulations of GCP and GMP regarding drug receipt, dispensing/preparation, storage and return of IMP/commercial and comparator.

RESPONSIBILITIES

• Release of IMP for use in human Clinical Trials at MAC Clinical Research
• Ensure compliance with MIA IMP
• Review and approve Technical Quality Agreements, Master Batch Records, Annex 13, Production and Pharmacy Manuals, and other applicable study documentation
• Review CTA, Annex 13 labels, IMPD, and other applicable submission documents for compliance
• Maintenance of the Product Specification File, and Pharmacy Files for studies under role lead
• Review and approve executed Batch Records, signed QP Certification for each batch, record batch certification and release, as applicable, 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
• Maintain professional qualifications required for the role, including continuous professional development
• 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 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
• To all items included in Job Description for Clinical Trials Pharmacist
• Any other Quality or Pharmacy tasks required

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
• Eligibility to act as a Clinical Trials Pharmacist is preferred, but not essential

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
• Eye Care Vouchers
• Cycle to work scheme
• 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.