QA Engineering and CSV

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

DUTIES AND RESPONSABILITIES

• 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 in order 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

REQUIREMENTS

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
• Firsthand experience of min 5 years in an Engineering / CSV position with confirmed experience in a Quality position
• Thorough knowledge in cGMP and international regulatory requirements
• Thorough knowledge in qualification and validation activities (equipment and computerized system)
• Fluent in French and English written and spoken
• Ability to make pragmatic and compliant decisions
• Strong result orientation and committed team member
• Good written and verbal communication skills.

Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 10 consulting companies in Switzerland. We have over 300 experienced engineers who share our passion.

Present in Switzerland, Singapore, and France, we support both Swiss and international clients in the following areas:

• Organizational and transformation consulting
• Information systems management

By joining our teams, you will discover:

• A dynamic team with a start-up mindset
• Personalized support and career development follow-up
• Opportunities to expand your network through exciting challenges
• A company certified @HappyAtWork and committed to CSR, awarded Ecovadis Gold Medal 2025

You too can be part of the Antaes adventure

Where applicable, the masculine form is used for readability purposes and is intended to be inclusive of all genders.