Senior Batch Record Reviewer

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland seeks a QA professional to review electronic batch records (eBRs) and ensure GMP-compliant, complete batch data for QA release. You will verify process steps, identify deviations, and support CAPAs and investigations while collaborating with cross-functional teams.

The role requires a Bachelor’s degree in a technical field, strong GMP knowledge, and English fluency with basic German (A2) or willingness to learn; onsite work in Visp with relocation support available.

Qualifikationen

• Bachelor’s degree or equivalent in Pharmacy, Engineering or related technical field.
• Strong understanding of GMP and bioprocess manufacturing.
• Ability to identify non-compliance and gaps from Quality standards.
• Experience in batch record review (preferred eBR) OR in manufacturing is required.
• Language Skills: English professional fluency and basic German (A2) or willingness to learn.

Aufgaben

• Perform timely and independent review of executed electronic batch records (eBRs) in MES Syncade.
• Ensure operations batch records are accurately executed, complete, and ready for QA review.
• Verify all process steps were performed as intended and GDP requirements followed; address deviations clearly.
• Support management of Quality Records (CAPAs, Deviations/Investigations) for batch record review observations.
• Assist Operations by resolving batch record execution issues and participate in MES Syncade Recipe improvements.
• Support batch release by ensuring timely closure of the Batch Record.

Kenntnisse

Batch record review

GMP knowledge

English fluency

German (A2)

Analytical thinking

Ausbildung

Bachelor’s degree in Pharmacy, Engineering or related field

Jobbeschreibung

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.

What you will get:

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.

What you will do:

• Perform timely and independent review of executed electronic batch records (eBRs) in MES Syncade
• Ensures that operations batch records are accurately executed, complete, and ready for QA review.
• Verify that all process steps were performed as intended, documentation follows GDP requirements, and any deviations or discrepancies are clearly identified and addressed.
• Support in the management of Quality Records (CAPAs, Deviations/Investigations) for Batch Record review related observations
• Support Operations by resolving Batch Record execution issues and participate in MES Syncade Recipe improvements
• Support in batch release by ensuring the timely closure of the Batch Record

What we are looking for:

• Bachelor’s degree or equivalent qualification in Pharmacy, Engineering, or a related technical field
• Strong understanding of GMP and bioprocess manufacturing
• Ability to identify non-compliance and gaps from Quality standards
• Experience in batch record review (preferred eBR) OR in manufacturing is required
• Language Skills: Professional Fluency in English and basic German proficiency (A2), or willing to learn.
• Structured, precise and well-organized working attitude; open-minded & pragmatic for new ideas and suggestions

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 is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.