Lead Computerized Systems QA & Data Integrity

Coopers Group; Oberwallis; On-site; CHF 110,000 - 170,000; Full time

Job summary

Coopers Group in Visp seeks a Computerized System QA Manager to establish and maintain a robust quality framework for GxP computerized systems, electronic records, and data integrity. You will ensure validation, operation, and oversight across CSV activities and related systems.

You will lead Data Integrity governance, support inspections, and drive continuous improvement with cross-functional teams while aligning with EU GMP Annex 11 and FDA 21 CFR Part 11 standards.

Qualifications

• Bachelor's or Master's in a related discipline.
• 5+ years' QA/CSV/Data Integrity in GMP environments.
• Experience leading or managing projects or teams.

Responsibilities

• Lead system validation across lifecycle and governance for CSV.
• Maintain data integrity, audit trails, and back-up/recovery.
• Ensure compliance with EU GMP Annex 11 and 21 CFR Part 11.
• Prepare for inspections and customer/regulatory audits.

Skills

CSV governance

Data Integrity

GxP QA oversight

Regulatory compliance

Leadership

Documentation practices

Education

Bachelor's or Master's in Computer Science/Engineering/Pharma

Tools

MES

LIMS

DMS

SAP

TrackWise

DeltaV

LMS

Job description

Coopers Group in Visp seeks a Computerized System QA Manager to establish and maintain a robust quality framework for GxP computerized systems, electronic records, and data integrity. You will ensure validation, operation, and oversight across CSV activities and related systems.

You will lead Data Integrity governance, support inspections, and drive continuous improvement with cross-functional teams while aligning with EU GMP Annex 11 and FDA 21 CFR Part 11 standards.