Senior Batch Record Reviewer for GMP QA Excellence

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

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.