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CK Group are recruiting for a Senior Quality Assurance Specialist to join a global pharmaceutical company on a contract basis for 12 months. This role is hybrid with 50% of time spent on site in Uxbridge.
Job Responsibility:
Responsible for QA vendor oversight
Manage contractor quality assurance activities
Identify and recommend quality-related improvements
Manage change control requests
Review batch records
Support GMP/GDP site inspections
Requirements:
Hold a relevant scientific degree or have equivalent working experience
In-depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
Ability to build relationships, partnerships and influence stakeholders
Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
Experience in interacting with external manufacturers and supporting quality at external manufacturing sites