Quality Systems Associate - Hertfordshire
James Horne is currently recruiting for a Quality Systems Associate to join a patient focused pharmaceutical research company with Commercial, Discovery, Clinical and Manufacturing business units collated on a single site in Hertfordshire on a permanent basis.
Your main responsibility will be to ensure that operations carried out within the Quality Systems section are completed in accordance with the requirements of the departmental Standard Operating Procedures.
You will support the effective running of the Product Quality Review, Quality Agreements, Complaints, Deviations, Parallel Imports, Risk Management, Qualification and Validation, Training, Standard Operating Procedures, Internal and External Audits and Approved Supplier Systems within company. You will ensure the Electronic TrackWise Quality Management System (QMS) and any associated systems used for the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and Corporate expectations.
Key responsibilities will include:
- Supporting the Product Quality Review process for the company.
- Supporting the process of generation of Quality Agreements.
- Supporting the process for approving suppliers and the maintenance of the Approved Suppliers List.
- Supporting the Complaints process of logging, review and investigation of Product Quality Complaints.
- Supporting the generation of the Quality Management Systems Indicator reports.
- Supporting the ongoing operation, maintenance and implementation of improvements to TrackWise processes.
- Writing and reviewing all SOPs associated with the Electronic TrackWise QMS.
You are required to have the following qualifications, skills and experience:
- Basic knowledge of Quality Assurance, Quality Systems, GMP and basic understanding of manufacture and packaging of pharmaceutical products.
- Good technical and scientific judgement.
- Diplomatic, self motivating, professional with problem solving and decision making capabilities.
- Basic understanding of GMP Guidelines and Regulations.
For more information or to apply for this position, please contact James on 0191 384 8905 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. 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 and 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 45034 in all correspondence.