Du übernimmst die Verantwortung für Qualifikationsaktivitäten, überprüfst Dokumente und führst interne Audits durch, während du auch Schulungen anbietest.
Anforderungen
- •Master’s degree in life sciences
- •GMP-regulated environment experience
- •Aseptic production experience
- •Greenfield project experience
- •At least 5 years’ experience in QA
- •Knowledge of GMP regulations (PIC/S, FDA)
- •Deviation and change processes familiarity
- •Computerized System Validation experience is a plus
- •Proactive and pragmatic quality mindset
- •Business fluent in German and English
Deine Aufgaben
- •Verantwortung für QA-Qualifikationsaktivitäten übernehmen
- •Design- und Qualifikationsdokumente überprüfen und genehmigen
- •Standortqualifikationsaktivitäten verbessern und umsetzen
- •An der Durchführung von Risikoanalysen (FMEA) teilnehmen
- •Abweichungen, Änderungen und CAPAs überprüfen und genehmigen
- •Ansprechpartner für Wartungs- und Kalibrierungsaktivitäten sein
- •GMP-Schulungen zu qualifikationsrelevanten Themen anbieten
- •Interne Audits durchführen
- •Qualitätsüberwachung bei wiederkehrenden Reviews, Requalifikationen und Validierungen bereitstellen
- •QA-Qualifikation während Kunden-Audits und Inspektionen der Gesundheitsbehörden vertreten
Deine Vorteile
Wertvolle Karriereentwicklungsmöglichkeiten
Flexible Arbeitsbedingungen
Zusammenarbeit mit erfahrenen Mitarbeitern
Vielfältige Schulungsangebote
Wettbewerbsfähige Pensionskassenregelung
Original Beschreibung
## QA Qualification Expert (d/f/m) 80-100%
###### Permanent employee, Full-time ·Visp,Basel
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##### Your mission
We're seeking a talented and dedicated **QA Qualification Expert** to join our dynamic team in Visp! If you have a strong background in Quality Assurance within the pharmaceutical industry and a passion for ensuring the highest standards, we want to hear from you.
Your responsibilities will include:
* Act as main responsible for assigned QA qualification activities
* Review and approval of design and qualification documents of facilities, utilities and equipment
* Drive, improve and implement the site qualification activities and respective strategies
* Participate in the execution of risk assessments (FMEA)
* Review and approve deviations, changes and CAPAs
* Act as contact person for maintenance and calibration activities
* Provide GMP training on Qualification relevant topics
* Execution of internal audits
* Provide quality oversight on periodic review, re-qualification and re-validation activities
* Represent QA Qualification during Customer Audits and Health Authority inspections
##### Your profile
We are looking for someone with:
* Master’s degree or higher in a life science related discipline
* Experienced in a GMP-regulated environment for Drug Product manufacturing or testing
* Experience in aseptic production
* Experience in greenfield projects
* At least 5 years’ experience in QA, Operations, Engineering or CQV
* Knowledge of relevant GMP regulations (PIC/S, FDA)
* Familiar with deviation & change processes
* Experience in Computerized System Validation and/or Process Validation is a plus
* Proactive and pragmatic quality mindset
* Business Fluency in German and English
##### Why us?
We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
Here's what sets ten23 apart:
* A valuable and impactful career development opportunity in an inspiring environment
* Flexible working arrangements and environment with an open culture and diverse workforce
* The opportunity to work with and learn from highly qualified and experienced employees
* Our learning and self-developing culture offers a wide range of training options
* Competitive pension fund plan, annual bonus, and other financial and non-financial benefit
At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.
##### About us
While most applicants fall short of 100% qualifications, we embrace diverse perspectives and encourage applications from all qualified candidates, regardless of background. Women & underrepresented groups, we see you!
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.