Senior QA Specialist, Batch Release 80-100% (f/m/d)

Lonza Biologics Porriño SLU; Visp; Vor Ort; CHF 80’000 - 110’000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der Biowissenschaft sucht einen Senior QA Specialist, um sicherzustellen, dass Produkte den nationalen und internationalen Anforderungen entsprechen. In dieser spannenden Rolle werden Sie Teil eines dynamischen Teams, das sich auf die Qualitätssicherung in der biotechnologischen Produktion konzentriert. Sie werden die Verantwortung für die Freigabe von Chargen übernehmen, als QA-Experte fungieren und an regulatorischen Inspektionen teilnehmen. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem agilen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Agile Karriere

Dynamische Arbeitskultur

Flexible Arbeitszeiten

Ethischer Arbeitsplatz

Qualifikationen

• Erfahrung in der Qualitätssicherung in einem GMP-Umfeld.
• Kenntnisse in biotechnologischen Herstellungsprozessen.

Aufgaben

• Freigabe von DS-Batches und Gewährung bedingter Freigaben für Rohstoffe.
• Überprüfung und Genehmigung von SOPs, Risikoanalysen und Abweichungen.

Kenntnisse

Qualitätssicherung (QA)

cGMP-Kenntnisse

Kommunikationsfähigkeiten

Agile und Lean Mindset

Ausbildung

Universitätsabschluss in Biotechnologie

Universitätsabschluss in Biologie

Universitätsabschluss in Chemie

Tools

TrackWise

LIMS

DMS

SAP

Jobbeschreibung

Senior QA Specialist, Batch Release 80-100% (f/m/d)

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

We are looking for a Senior QA Specialist, Batch Release (m/f/d) for the Mammalian Business Unit in Visp.

The Senior QA Specialist ensures that manufactured products comply with national and international requirements and cGMP standards throughout their entire lifecycle. As a Quality representative, she/he will be a key member in cross-functional teams ensuring measures for product safety, product quality, and cGMP compliance are implemented. The Senior QA Specialist will have delegation from the Lonza Visp FvP and will be responsible for the conditional releases.

What you’ll get:

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• Flexible working arrangements

What you’ll do:

• Disposition of DS batches: Release/block/reject of Drug Substance produced in DD DS (Mammalian) on behalf of the Responsible Person/FvP (Fachtechnisch Verantwortliche Person) according to articles 4, 5, and 7 AMBW
• Grant conditional releases (SF) for raw materials and intermediates and authorization for quarantine shipments on behalf of the responsible person
• Act as QA expert (SME) for DS disposition and SF, providing recommendations and suggestions in these areas
• Review and approve records such as SOPs, Quality Risk Assessments, Deviations, CAPAs, Change Requests, Effectiveness Checks, etc., where applicable
• Identify emerging QA relevant topics and develop them into new or established Quality and Compliance strategies and standards
• Participate in and support regulatory inspections and customer audits; serve as SME for such topics in front of inspectors and auditors when necessary

What we’re looking for:

• University Degree in Biotechnology, Biology, Chemistry, Life Science, or related field
• Solid QA experience in GMP environment
• Strong background in cGMP and broad knowledge of biotechnological manufacturing processes
• Experience with systems such as TrackWise, LIMS, DMS, and SAP is preferred
• Excellent communication skills and experience interacting with various interfaces within the organization and with regulatory agencies (Swissmedic, FDA, etc.)
• Agile and lean mindset
• Proficient in written and spoken English; German knowledge is an advantage

At Lonza, we respect and protect our people and environment. Success is only meaningful if achieved ethically. We value the challenge and creativity involved in solving complex problems and developing new ideas in life sciences, offering the satisfaction of improving lives worldwide and making a meaningful difference.