We are supporting a global CRO who want a Qualified Person (IMP) to join their team at their new steriles facility in Leeds.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
Pharmacy, Biological or Chemical Science degree
Member of recognised professional body (Royal Pharmaceutical Society GB, Royal Society of Chemistry or Institute of Biology)
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 (including staff):
- Certification of IMP under MIA IMP licence under directive 2001/20/EC Article 13
- Release of IMP for use in human Clinical Trials
- Facilities according to 2001/20/EC article 9 to ensure subject safety
- Ensure compliance with MIA IMP
- 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
- 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 health and Safety policy
- Compliance with 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 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
PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS:
QP activities may be carried out at other sites or remotely and occasional travel between sites and to participate in inter-site meetings or problem-solving groups.
All applicants MUST have the right to work in the UK as this role will not offer sponsorship.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
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