Senior QA, Change Control Specialist (m/f/d)

Lonza • Vollzeit • Visp, Schweiz • vor 1d

Today, Lonza is a global leader in life sciences operating across three 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.

As a member of the QA Projects and Change Controls group in BioAtrium, the Change Control Specialist (f/m/d) supports in QMS GMP compliance (e.g. hosting CCRB, supporting raising and closure of changes), promotes the adherence and continuous improvement of Quality Systems and ensures Quality oversight in the specified area.

Key responsibilities:

Owns quality records such as change controls, CAPAs, investigations, effectiveness checks in line with valid SOPs
Leads the Change Control Review Board (CCRB)and CAPA Review Board (CRB) as required
Hosts change control clinics to support Production, MSAT, validation, CQV and other Quality members with change controls
Authors, reviews and approves GMP-relevant documents and SOPs in the ownership of QA
Supports and participates in internal, customer and regulatory audits
Electronic batch record: recipe review and approval
Support continuous improvements programs to establish effective Quality Management Systems

Key requirements:

Bachelor or Master Degree in life sciences (e.g. chemistry, biotechnology or a related field)
Significant work experience in the GMP-regulated industry; preferably in the following units: Production, QC or QA, Operations
Broad knowledge in Quality standards (e.g. ICH Q7, 21 CFR Part 11
Knowledge of electronic systems such as Delta V, Syncade, SAP, LIMS, Trackwise an advantage
English language skills (written and spoken) are required, German is an advantage

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza

Jetzt bewerben

Diesen Job teilen

Jobs, die dich ebenfalls interessieren könnten ...

Head HR Small Molecules Visp (f/m/d)

Lonza • Vollzeit • Visp, Schweiz • vor 23h

Administration / HR / Consulting / CEO

vor 23h

Bewerben

Head Quality Systems & Compliance (m/w/d)

Lonza • Vollzeit • Visp, Schweiz • vor 23h

Administration / HR / Consulting / CEO

vor 23h

Bewerben

Senior Manager - Operational Excellence Manager (f/m/d)

Lonza • Vollzeit • Visp, Schweiz • vor 23h

Administration / HR / Consulting / CEO

Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there's no magic formula to how they do it. Their greatest scientific solution is talented people working...

vor 23h

Bewerben

Training and Documentation Expert Drug Product (f/m/d)

Lonza • Vollzeit • Visp, Schweiz • vor 23h

Administration / HR / Consulting / CEO

Today Lonza is a global leader in life sciences operating across three 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,...

vor 23h

Bewerben

Operational Readiness Planner (m/w/d) - Pharma

Turner & Townsend • Vollzeit • Visp, Schweiz • vor 23h

Administration / HR / Consulting / CEO

Unternehmensbeschreibung Turner & Townsend zählt zu den führenden, globalen Projektmanagement- und Bauberatungsunternehmen. Mit einem internationalen Netzwerk aus über 10.000 Mitarbeiter:innen in 48 Ländern unte...

vor 23h

Bewerben

Lead Project Planner/Scheduler (m/w/d) - Pharma

Turner & Townsend • Vollzeit • Visp, Schweiz • vor 23h

Administration / HR / Consulting / CEO

vor 23h

Bewerben

Technischer / GMP Trainer 80-100% (m/f/d)

Lonza • Vollzeit • Visp, Schweiz • vor 1d

Administration / HR / Consulting / CEO

Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences mit mehr als 100 Produktionsstandorten und Niederlassungen sowie rund 15'000 Vollzeitmitarbeitenden weltweit. Wir sind in der Wissenschaft tätig...

vor 1d

Bewerben

EHS Manager Process Safety (m/w/d)

Lonza • Vollzeit • Visp, Schweiz • vor 1d

Administration / HR / Consulting / CEO

vor 1d

Bewerben

Senior QA Specialist, Project Manager (w/m/d)

Lonza • Vollzeit • Visp, Schweiz • vor 1d

Administration / HR / Consulting / CEO

Titel : Senior QA Specialist - Small Molecules Umzugsunterstützung für geeignete Kandidaten möglich Hybrides Arbeitsmodell Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, das auf drei Kon...

vor 1d

Bewerben

EHS Manager Process Safety (m/w/d)

Lonza • Vollzeit • Visp, Schweiz • vor 1d

Administration / HR / Consulting / CEO

vor 1d

Bewerben