Beschreibung
Qualification/Validation Expert (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Executes establishment and maintenance of Equipment Qualification System
- Ensures the proper qualification of equipment/instruments/computerized-systems by ensuring adherence to the corresponding VMP
- Act as first contact for equipment qualification & maintenance within QA; e.g. author of overarching documents around instrument qualification
- Act as first contact concerning equipment qualification document life cycle management; e.g. approval of instrument SOPs, qualification protocols and reports
- Acts as first contact concerning compliance issues for equipment qualification in shared global systems (e.g. LIMS, DMS, SAP, COMOS, Unifier, Trackwise)
- Supervises and executes compliance activities
- Ensures the proper qualification of staff by supervising adherence to GMP trainings
- Ensures the proper qualification of equipment supplier /services by supervising adherence to quality agreements and audit observations
Main qualifications
- Academic degree in Engineering, Pharmaceutical Technology, natural science or related field
- Working experience in pharmaceutical industries and GMP controlled environment preferable in Quality Control, Production or Quality Assurance.
- Extended experience from participation in audits and authorities' inspections
- Very good working knowledge in EU and US GMP regulations relevant for equipment qualification, maintenance and corresponding compliance systems
- Very good knowledge in EU and US GMP regulations relevant for computerized systems validation
- Experience in data base assisted maintenance monitoring systems
Main advantages:
- A very renowned company
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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