GMP CSV QA Engineer – Validation & Compliance

Tech'Firm Industrie AG

Basel

Vor Ort

CHF 120.000 - 150.000

Vollzeit

Vor 2 Tagen

Sei unter den ersten Bewerbenden

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Zusammenfassung

Techfirm Industrie AG in Basel seeks a QA CSV Engineer to ensure quality and compliance of computerized systems throughout their lifecycle in a GMP environment. You will work with QA, IT, CSV, Engineering and Manufacturing to implement and maintain validated systems. The role requires 3–5 years in CSV within GMP-regulated settings, strong documentation skills, and knowledge of data integrity principles.

English fluency is required; German is a plus. Work location: 4001 Basel (BS).

Qualifikationen

3–5 years of professional CSV experience in GMP environments.
Experience with CSV lifecycle activities and risk-based validation.
Knowledge of GMP/GxP regulatory requirements related to computerized systems.
Experience with validation documentation (URS, risk assessments, test protocols, traceability).
Familiarity with Data Integrity/ALCOA+ concepts.

Aufgaben

Plan, coordinate and execute CSV activities in GMP settings.
Support validation lifecycle from requirements to operation.
Prepare and maintain validation docs (Validation Plans, URS, RTMs).
Assist IQ/OQ/PQ testing and user acceptance testing.
Ensure systems are validated per GMP, GxP and internal standards.
Contribute to risk-based validation strategies and change controls.
Support audits and regulatory inspections with QA perspective.
Collaborate with IT, QA, Engineering, Manufacturing and owners.

Kenntnisse

CSV lifecycle

GMP/GxP

Documentation

Audit support

Data Integrity

Cross-functional

Communication

Ausbildung

Master's degree

Tools

MES

LIMS

SAP/ERP

SCADA

BMS

Quality Mgmt System

Jobbeschreibung