Location : Lausanne, Switzerland  

Who is Aixial Group ?

Aixial Group, we are a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.

Since 2014, we have been part of the Alten family.

We are developing our activities in Switzerland, France, Belgium, Czech Republic, Denmark, UK, US…with even more prospects for expanding internationally.

Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,… activities in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR…

Aixial Group continues to grow, and to recruit in the clinical trial professions. Come and join us, and discover our site to follow the news of our offers.

The Team of Aixial Group Switzerland is looking for his next CSV – GCP Officer (M/F) !

As a CSV – GCP (M/F), you will play a pivotal role in ensuring the compliance, integrity, and efficiency of computerized systems across the organization.

Your responsibilities will encompass various aspects of Computer System Validation (CSV) to uphold regulatory requirements and standards, through Clinical activities.

RESPONSIBILITIES:

• Collaborate with the CSV-GCP Lead and other team members to evaluate, design, optimize, and implement the Computer System Life Cycle (CSLC)/CSV strategy.
• Assist in translating the CSV strategy into specific procedural documents tailored to individual systems.
• Participate in planning and overseeing CSV activities, ensuring adherence to established methodologies and standards.
• Support the Vendor/system selection and qualification process, reviewing Vendor procedures and CSV documentation to ensure regulatory compliance.
• Work closely with relevant stakeholders to ensure proper system setup, oversight of Vendor activities, and alignment with GxP requirements.
• Contribute to CSV Project Teams for specific computerized systems as required.
• Contribute to the CSLC/CSV approach, ensuring consistency and compliance throughout the validation process.
• Collaborate cross-functionally to develop, review, and approve CSV deliverables.
• Participate in verification activities, test defect verification, and risk management activities.
• Participate in implementation of maintenance and support activities
• Provide ongoing support to internal stakeholders on CSV procedures and regulations.
• Identify areas for improvement in CSV processes and infrastructure qualification, and contribute to the development of corrective actions.
• Train and mentor staff on CSV activities and ensure compliance with organizational standards.

REQUIREMENTS :

• Minimum Master’s degree in science, engineering, or a clinical field.
• At least 6-8 years of experience in Quality Management within the pharmaceutical industry, with a focus on CSV and qualification activities in Clinical field.

• Preferred experience in managing and conducting audits.
• Good understanding of GxP regulations and validation requirements, including ICH GCP E6, 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Ability to work effectively in cross-functional teams.
• Strong commitment to efficiency, continuous improvement, and compliance.
• Strategic thinking and ability to apply a risk-based approach to decision-making.
• Proficiency in English; French language skills are an asset.

Why Join Us?

• Make a positive impact and be at the forefront of project: You will be part of ground breaking advancement in clinical research that has positive impacts on millions of people’s lives globally.

• Career Development: People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.

• Our commitment to Diversity, Equality, and Inclusion: We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best. Gender equality is at the core of the development strategy of Aixial Group.

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