Senior QA, Change Control Specialist

Vor 3 Tagen

Visp, Schweiz Lonza Vollzeit

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.

Reference: R61366

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