Quality Assurance Expert, Instrument Qualification

Responsibilities

• Ensures the proper qualification of equipment/instruments/computerized-systems by ensuring adherence to the corresponding VMP(s).
• Acting as first contact for equipment qualification & maintenance within QA;
• Acting as first contact concerning equipment qualification document life cycle management; e.g. approval of instrument SOPs, qualification protocols and reports
• Acting as first contact concerning compliance issues for equipment qualification in shared global systems (e.g. LIMS, DMS, SAP, Trackwise)
• Supervises and executes compliance activities like GMP status and trending of equipment qualification/re-qualification in relation to supplier qualification, changes, non-conformities, CAPAs, document management;
• Ensures the proper qualification of equipment supplier /services by supervising adherence to quality agreements and audit observations
• Tracking GMP status of equipment/instruments/computerized-systems

Requirements:

• Bachelor’s degree in a scientific, engineering, or related field (e.g., Chemistry, Biology, Biotechnology, or Engineering). Advanced degree preferred.
• Minimum of 3–5 years of experience in Quality Assurance, Quality Control, or Equipment Qualification in a GMP-regulated environment.
• Familiarity with regulatory standards and guidelines (e.g., FDA, EMA, ICH Q8–Q10, ISO 9001) relevant to GMP environments.