Job Description
Job Title: Quality Operations Associate
Job Type: 12-month Fixed Term Contract (FTC, MAT Cover)
Location: Hertfordshire, UK – On-site
Supporting Quality Systems and Assurance activities for the manufacture, packaging, testing, storage and distribution of onsite manufacturing and third party contract manufactured drug products, ensuring compliance with current GMP, Quality Systems, Corporate expectations and Industry Standards Support the review and writing of quality policies, systems and procedures as required.
Support the effective implementation, by all stakeholders, of aspects of the operational Quality Management System (QMS), including, but not limited to, Product Quality Reviews, Quality Agreements, Parallel Imports, Change Control, Risk Management, Deviations/Incidents, Training, Documentation, Internal and External Audits, Approved Supplier Systems and use of the TrackWise eQMS.
Responsibilities:
1. To ensure that operations conducted are performed in accordance with the requirements of Corporate Standards, Quality System, GMP and GDP Guidelines and Industry Standards.
2. To support the Product Quality Review process for EML.
3. To support the process of generation of Quality Agreements.
4. To support the proce...