Quality Specialist 2

2 weeks ago


Glasgow, United Kingdom Merck Group Full time

The Quality Validation Auditor reports to the Quality Manager/Supervisor and carries out assigned tasks with competence, undertaking any other reasonable duties assigned by Quality Assurance Management, while constantly working within Operational departments to reduce the risk of quality findings.

Responsibilities include:

  1. Reviewing and approving validation documents against regulatory and internal requirements, encompassing requirements, risk assessments, protocols, testing, final/summary reports, trace matrix, etc.
  2. Reviewing and approving minor, major, and critical impact deviations/OOS records.

Who You Are:
Bachelor of Science (B.S.) degree in biological science or relevant technical area. 1+ years' experience in Quality Assurance or related field within a GxP environment, ideally GMP. Works with cross-functional teams and builds networks within QA and Operations departments. Knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity, Part 11/Annex 11). Strong communication and interpersonal skills.

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