Qualified Person (QP) - Hertfordshire
CK Group is recruiting for a Qualified Person (QP) to join a pharmaceutical company at their facility based in Hertfordshire on a contract basis for 1 year.Your main responsibilities in this role will be to:
Provide QP certification of batches of IMPs packaged for Clinical Trial use as required by directive 2001/20/EC.
Complete audits to ensure compliance to SOPs, GMPs and applicable regulations.
Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review and QP certification.
Manage product recalls and stock recoveries as appropriate.
Identify compliance gaps, make and facilitate implementing recommendations for continuous improvement.
Create and maintain assigned SOPs.
Perform and review complaints and deviation investigations, change controls and CAPA's.
Assist in the induction process for new starters and training of other staff.
Generally follow standard procedures and work with manager/supervisor to ensure resolution of exceptions.
Compile data for reports and presentations, provide data interpretation & draw conclusions.
Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
Keep abreast of cGMP requirements as described in applicable worldwide regulations.
Represent department on cross functional teams.
Audit external suppliers, issuing audit reports and assessing corrective actions to close out reports.
Review and approval of Technical & Quality Agreements.
Lead the departmental and site preparation for external audits (e.g. HA Inspections).
Independent development, documentation and maintenance of business process and solutions.
Expert knowledge in specialised areas of technical expertise.
Direct management responsibilities for assigned staff including resourcing, training, setting and reviewing objectives, providing feedback and staff development.
Additional activities as assigned by the manager/supervisor.You are required to have the following qualifications, skills and experience:
Degree/MSc/Phd (or equivalent) in a Science subject.
You will have a sound knowledge of GMP requirements for Clinical Trials.
Experience of working in the Pharmaceutical industry is essential.This is an excellent opportunity to join a globally represented pharmaceutical company at their site located in Hertfordshire with good commuting links to London.Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.CK Group is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA41994 in all correspondence