Biopharma Batch Record Reviewer — GDP/eBR Expert

Lonza Group AG; Oberwallis; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Zusammenfassung

Lonza Group AG in Visp, Switzerland, is seeking a Batch Record Reviewer to ensure accurate eBR reviews and timely batch closures in our biopharma manufacturing setting.

The ideal candidate holds a Bachelor's degree in a life sciences field, understands GMP principles, and has hands-on experience with batch records (eBR) or biomanufacturing, preferably with MES Syncade. English fluency is required, German knowledge is a plus.

Qualifikationen

• Bachelor's degree in Pharmacy, Engineering, Chemistry, or related life sciences.
• Foundational GMP knowledge and bioprocess understanding.
• Hands-on batch record review experience (eBR) preferred.
• Familiarity with MES software, ideally MES Syncade.
• Fluent English; basic German helpful.

Aufgaben

• Perform timely and independent reviews of executed electronic batch records (eBRs) within MES Syncade for Module P Bufferprep.
• Safeguard patient safety and quality by ensuring all operations batch records are accurately executed, complete, and fully prepared for QA release.
• Verify that bioprocess manufacturing steps were conducted as intended and align strictly with Good Documentation Practice (GDP) standards.
• Proactively identify, investigate, and resolve non-compliance issues, gaps, or discrepancies prior to final batch release.
• Collaborate closely with cross-functional manufacturing and Quality Assurance teams on site to ensure rapid batch closure cycles.
• Gain high-visibility experience and develop professional expertise within a state-of-the-art biopharmaceutical manufacturing environment.

Kenntnisse

GMP principles

Batch record review

MES Syncade

Analytical mindset

English proficiency

Ausbildung

Bachelor's degree in Pharmacy/Engineering/Chemistry or related life sciences

Tools

MES Syncade

Jobbeschreibung

Lonza Group AG in Visp, Switzerland, is seeking a Batch Record Reviewer to ensure accurate eBR reviews and timely batch closures in our biopharma manufacturing setting.

The ideal candidate holds a Bachelor's degree in a life sciences field, understands GMP principles, and has hands-on experience with batch records (eBR) or biomanufacturing, preferably with MES Syncade. English fluency is required, German knowledge is a plus.