CSV – GCP Officer
vor 1 Woche
Location:
Lausanne, Switzerland Who is Aixial Group? Aixial Group is a CRO (Clinical Research Organization) specializing in Life Science. We collaborate with laboratories to provide technical support on clinical projects spanning phases I to IV and post-market. Since 2014, we have been part of the Alten family, expanding our activities globally. Aixial Group operates in outsourcing and insourcing for pharmaceutical, cosmetic, medical device, biotechnology, nutrition, and more. Our focus includes clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, and HEOR. Aixial Group is growing and recruiting in the clinical trial professions. Join us and explore our website for the latest updates. The Team of Aixial Group Switzerland is seeking a CSV – GCP Officer (M/F) As a CSV – GCP Officer (M/F), you will play a crucial role in ensuring the compliance, integrity, and efficiency of computerized systems across the organization. Your responsibilities will involve various aspects of Computer System Validation (CSV) to meet regulatory requirements and standards in clinical activities.
RESPONSIBILITIES:
- Collaborate with the CSV-GCP Lead and the team to assess, design, optimize, and implement the Computer System Life Cycle (CSLC)/CSV strategy.
- Aid in translating the CSV strategy into specific procedural documents tailored to individual systems.
- Engage in planning and overseeing CSV activities, ensuring adherence to established methodologies and standards.
- Assist in the Vendor/system selection and qualification process, reviewing Vendor procedures and CSV documentation for regulatory compliance.
- Work closely with 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 needed.
- Contribute to the CSLC/CSV approach to ensure 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.
- Engage in the implementation of maintenance and support activities.
- Provide continuous support to internal stakeholders on CSV procedures and regulations.
- Identify areas for enhancement in CSV processes and infrastructure qualification, and contribute to corrective action development.
- Train and guide staff on CSV activities, ensuring compliance with organizational standards.
REQUIREMENTS:
- Minimum Master's degree in science, engineering, or a clinical field.
- 6-8 years of experience in Quality Management within the pharmaceutical industry, focusing on CSV and qualification activities in the Clinical field.
- Previous experience in managing and conducting audits.
- Profound understanding of GxP regulations and validation requirements, including ICH GCP E6, 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Ability to work efficiently in cross-functional teams.
- Strong dedication to efficiency, continuous improvement, and compliance.
- Strategic thinking and application of a risk-based approach to decision-making.
- Proficiency in English; knowledge of French is beneficial.
Career Development:
People are our greatest asset. We are dedicated to continuously empowering our team and fostering a positive, supportive environment that encourages growth, flexibility, and teamwork. At Aixial Group, you will be mentored throughout your journey, aiding in your professional and personal development.
Our commitment to Diversity, Equality, and Inclusion:
Our goal is to create a workforce that upholds dignity and respect, where individual differences are acknowledged and appreciated, allowing each employee to contribute their best. Gender equality is fundamental to Aixial Group's development strategy.
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