Quality Assurance Expert, Instrument Qualification LZAJP00005054
vor 1 Tag
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.
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