Quality Assurance: Batch Record Reviewer (GMP)

Lonza; Oberwallis; On-site; Vertraulich; Full time

Benefits offered by this job

Site-based role in Visp

Dynamic working culture

Inclusive workplace

Job summary

Lonza in Visp, Switzerland, is seeking a Batch Record Reviewer to ensure flawless compliance, data integrity, and operational excellence in critical production projects. The role is fully site-based, enabling real-time collaboration and precise manufacturing.

You will review batch records, collaborate with Manufacturing and Quality, and analyze records in MES Syncade, DeltaV, TrackWise, SAP, and LIMS to uphold GDP and ALCOA+ standards.

Qualifications

• GMP knowledge and exposure to a GMP-regulated manufacturing or QA environment.
• Strong understanding of GDP and ALCOA+ data integrity principles.
• Hands-on with electronic batch records and quality management systems.

Responsibilities

• Ensure timely release and compliance of medicines by performing batch record reviews.
• Collaborate with Manufacturing and Quality to investigate batch discrepancies.
• Analyze electronic and paper batch records across MES/ERP/LIMS systems.
• Evaluate process parameter failures and material usage with GDP/ALCOA+ guidance.
• Draft clear quality impact statements and post-production documentation.
• Drive continuous improvement and data integrity across site production lines.

Skills

GMP knowledge

GDP/ALCOA+ data integrity

Problem solving

Independent worker

English fluency

Education

Degree in Life Sciences/Biology/related field

Tools

MES Syncade

DeltaV

TrackWise

SAP

LIMS

Job description

Lonza in Visp, Switzerland, is seeking a Batch Record Reviewer to ensure flawless compliance, data integrity, and operational excellence in critical production projects. The role is fully site-based, enabling real-time collaboration and precise manufacturing.

You will review batch records, collaborate with Manufacturing and Quality, and analyze records in MES Syncade, DeltaV, TrackWise, SAP, and LIMS to uphold GDP and ALCOA+ standards.