Batch Record QA Reviewer - Safeguard Life-Saving Medicines

Lonza Group AG; Eyholz; On-site; CHF 90,000 - 115,000; Full time

Benefits offered by this job

On-site role

Competitive benefits

Job summary

Lonza Group AG is seeking a Batch Record Reviewer to join our Quality Assurance team in Visp. You will ensure timely, compliant batch record reviews and partner with Manufacturing and Quality to resolve discrepancies.

You will analyze electronic and paper batch records within state-of-the-art MES (Syncade), DeltaV, SAP, TrackWise, and LIMS environments, ensuring GDP data integrity and adherence to ALCOA+ principles.

Qualifications

• Degree in Life Sciences or related field and GMP environment experience.
• Experience with electronic batch records and quality systems.
• Solid GDP/ALCOA+ data integrity understanding.

Responsibilities

• Perform timely batch record reviews to ensure release compliance.
• Collaborate with Manufacturing and Quality to investigate batch discrepancies.
• Analyze electronic and paper batch records in MES, DeltaV, SAP and TrackWise.
• Evaluate parameter failures, material consumption, and operator notes for data integrity.
• Draft quality impact statements and production lifecycle documentation.
• Support continuous improvement and data integrity across production lines.

Skills

Batch record review

GMP experience

Data integrity (ALCOA+)

Problem solving

Independent working

English proficiency

Education

Life Sciences degree

Tools

MES Syncade

DeltaV

TrackWise

SAP

LIMS

Job description

Lonza Group AG is seeking a Batch Record Reviewer to join our Quality Assurance team in Visp. You will ensure timely, compliant batch record reviews and partner with Manufacturing and Quality to resolve discrepancies.

You will analyze electronic and paper batch records within state-of-the-art MES (Syncade), DeltaV, SAP, TrackWise, and LIMS environments, ensuring GDP data integrity and adherence to ALCOA+ principles.