Quality Systems Associate

We are looking for a Quality System Associate on behalf of our client based in Hertfordshire

The ideal candidate would have experience in:

* Change Controls
* Qualification and Validation documentation
* Knowledge of control of Regulatory Information
Details of responsibilities:

* To support the Product Quality Review process for company.
* To support the process of generation of Quality Agreements.
* To support the process for approving suppliers and the maintenance of the Approved Suppliers List.
* To support the maintenance of a list of Parallel Importers/Distributors of Eisai products as compiled from notifications and samples received by CompnayRegulatory Affairs.
* To support the generation of the Quality Management Systems Indicator reports.
* To support the ongoing operation, maintenance, and implementation of improvements to TrackWise processes and systems to meet companyneeds.
* To supportTraining Management System.
* To maintain copies of Corporate Policies, Guideline, Standards and Procedures.
* To write and review all SOPs associated with the Electronic TrackWise QMS
* To support the company SOP System.
* To support the internal and external audit process and audit schedules
* To participate in Audits
* To support Quality Systems training ofstaff, as required.
* To coordinate and support GMP Training
* To support the Deviations System
* To support theRisk Management System
* To 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
* To perform any appropriate duties at the request of the Quality Systems Manager.