Leeds, West Yorkshire, England, UKLeedsWest YorkshireUKLS10 1DU
Job Ref:
BBBH126747
Sector:
Clinical
Sub-sector:
Pharmaceuticals
Date Added:
13 March 2023
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SRG are a strategic recruitment partner to an UK based medical research organisation who are looking for a Qualified Person QP (IMP) to join the...
Job Title: Qualified Person QP (IMP)
Location: Leeds
Contract: Permanent
Salary: Competitive
Shift: Mon- Fri (business hours)
SRG are a strategic recruitment partner to an UK based medical research organisation who are looking for a Qualified Person QP (IMP) to join the team in Leeds.
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 at the company's Clinical Research
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 the company's health and Safety policy
Compliance with the company's 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 the company's 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 the company and to represent the client appropriately in a professional way to all our customers
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)
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
If this role is of interest to you, (or you know anyone who might be suitable), please click the link to apply or email your CV to Natalia Santoro at
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.