QA-CSV & Digitalization Site Lead (Checklyst)

Amaris Consulting | Part of Mantu; Beerse; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Amaris Consulting | Part of Mantu in Belgium is seeking a QA-CSV specialist to oversee validation and digital systems within a GxP manufacturing environment. You will serve as independent QA-CSV oversight for execution systems and act as Site Key User for Checklyst Manager, driving digital transformation, data integrity, and compliant records across the site.

The role requires collaboration with cross-functional teams, risk-based validation, change control, and timely closure of records, with

Qualifikationen

• 4–7 years’ experience in CSV, validation, QA/quality assurance in a GxP-regulated setting.
• Lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state.
• Experience supporting system users, coordinating stakeholders, or acting in a key-user or application-support role.
• Solid knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity expectations.
• Understanding of risk-based validation, electronic records and signatures, access controls, audit trails, and data transfer.

Aufgaben

• Provide QA-CSV oversight for PLC/SCADA-based systems and automation networks, and for digital checklists in Checklyst Manager.
• Review and approve validation deliverables and traceability documentation.
• Assess changes, deviations, CAPAs for impact on product quality and data integrity.
• Coordinate onboarding, testing, documentation, access governance, and metrics for digital workflows.

Kenntnisse

CSV validation experience

Quality assurance

Digital systems

GxP environment

English fluency

Ausbildung

Bachelor/Master in Engineering or Life Sciences

Tools

SIMATIC Logon

Active Directory

Checklyst Manager

GAMP 5

Jobbeschreibung

Amaris Consulting | Part of Mantu in Belgium is seeking a QA-CSV specialist to oversee validation and digital systems within a GxP manufacturing environment. You will serve as independent QA-CSV oversight for execution systems and act as Site Key User for Checklyst Manager, driving digital transformation, data integrity, and compliant records across the site.

The role requires collaboration with cross-functional teams, risk-based validation, change control, and timely closure of records, with