Senior QA Engineer — CSV & cGMP Compliance

Antaes Consulting; Lausanne; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Benefits dieser Stelle

HappyAtWork certified

CSR initiative

Ecovadis Gold Medal 2025

Zusammenfassung

Antaes is a Swiss management and technology consulting firm seeking a QA/CSV lead to oversee Commissioning, Qualification, and validation activities within cGMP-compliant environments.

You will collaborate with Engineering and IT/CSV teams to prevent issues, approve validation deliverables, and drive CAPA and continuous improvement initiatives. Fluency in French and English is required, with a degree in science or engineering.

Qualifikationen

• 5+ years in an Engineering/CSV role with Quality exposure.
• Thorough knowledge of cGMPs and international regulatory requirements.
• Experience in qualification and validation (equipment and computerized systems).
• Fluent in French and English (written and spoken).
• Strong decision making and team collaboration.
• Excellent written and verbal communication.

Aufgaben

• Ensure quality oversight of the Commissioning & Qualification, Utilities, Calibration and Maintenance activities.
• Ensure quality oversight of computerized systems lifecycle activities according to GAMP 5, Annex 11 and 21 CFR Part 11 requirements.
• Ensure compliance of Engineering and CSV activities with cGMPs and approved procedures.
• Partner with Engineering departments and IT / CSV teams to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events.
• Review and approve SOPs to ensure efficiency of the process and compliance with Incyte Policies and regulatory requirements.
• Assess and approve validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Validation Reports).
• Review and approve data audit trail, system audit trail and periodic review of systems used at the BioPlant.
• Review and approve deviations and investigations in the area of responsibility. Escalate as appropriate to management major / critical issues.
• Recommend and approve CAPA plans and ensure timely implementation.
• Review, assess and approve implementation of changes in the area of responsibility.
• Contribute to the elaboration of risk assessments in the area of responsibility.
• Contribute to continuous improvement initiatives in the area of responsibility.
• Support Inspection readiness activities and represent QA function for Engineering and CSV department in Health Authorities inspections.
• Support the internal audit and GMP tour programs.
• Foster compliant and right first time activities.
• Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by Bioplant employees.

Kenntnisse

Quality oversight

CSV (Computer System Validation)

GAMP 5

Regulatory compliance

Risk assessment

CAPA management

SOP review

Documentation

Team collaboration

Decision making

Ausbildung

Science degree

Tools

GAMP 5

Jobbeschreibung

Antaes is a Swiss management and technology consulting firm seeking a QA/CSV lead to oversee Commissioning, Qualification, and validation activities within cGMP-compliant environments.

You will collaborate with Engineering and IT/CSV teams to prevent issues, approve validation deliverables, and drive CAPA and continuous improvement initiatives. Fluency in French and English is required, with a degree in science or engineering.