Quality Systems Associate
A leading pharmaceutical client is searching for a Quality Systems Associate to join their team in the UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.
- Support the Product Quality Review process for EML.
- Support the process of generation of Quality Agreements.
- Support the process for approving suppliers and the maintenance of the Approved Suppliers List.
- Support the Complaints process of logging, review and investigation of Product Quality Complaints.
- Support the maintenance of a list of Parallel Importers/Distributors of company products as compiled from notifications and samples received by Regulatory Affairs.
- Support the generation of the Quality Management Systems Indicator reports.
- Support the ongoing operation, maintenance and implementation of improvements to TrackWise processes and systems to meet EMLs needs.
- Support EML's Training Management System.
- Maintain copies of Corporate Policies, Guideline, and Standards and Procedures.
- Write and review all SOPs associated with the Electronic TrackWise QMS
- Support the EML SOP System.
- Support the internal and external audit process and audit schedules.
- Participate in Audits.
- Support the EML Change Control System.
- Support the review and approval of Qualification and Validation documentation.
- Support the control of Regulatory Information within EML.
- Support Quality Systems training of EML staff, as required.
- Coordinate and support GMP Training.
- Support the Deviations System.
- Support the EML Risk Management System.
- Provide day to day support to other members of the Quality Systems team, as appropriate.
- Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working
- Perform any appropriate duties at the request of the Senior Manager Regional Quality Systems.
Skills and Requirements:
- Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers.
- Extensive knowledge of Quality Assurance, Quality Systems, GMP, Regulatory Compliance, and manufacture and packaging of pharmaceutical products.
- Good technical and scientific judgement.
- Ability to interpret complex data and present key findings.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Godden at +442038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Bad Homburg vor der Höhe (61348), Germany
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