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GxP Validation Specialist
1 week ago
Job Summary
">We are seeking a highly skilled GxP validation expert to join our team at Archimedis. The ideal candidate will possess in-depth knowledge of regulatory requirements, including 21 CFR Part 11, EU Annex 11, and GAMP 5.
">Key Responsibilities:
">- ">
- Lead GxP validation activities and ensure compliance with regulatory requirements.">
- Develop and execute test cases, leveraging CSA principles.">
- Prepare and maintain validation documentation, including validation plans, risk assessments, and final reports.">
- Provide guidance and mentorship to project teams on GxP validation methodologies and industry best practices.">
- Collaborate with cross-functional teams to align validation strategies with customer expectations and regulatory requirements.">
Required Skills & Experience:
">- ">
- 5 years of experience in GxP validation, with a strong background in CSA-based validation.">
- Hands-on experience in test case creation, execution, and validation documentation.">
- Deep understanding of GxP regulations and industry guidelines.">
- Strong analytical and critical thinking skills.">
- Ability to lead validation projects, manage timelines, and collaborate with cross-functional teams.">
- Experience with ETL testing, Automation testing, or AI/ML testing is mandatory.">
Preferred Qualifications:
">- ">
- Experience working in Life Sciences, Pharmaceuticals, or Medical Devices industries.">
- Familiarity with validation in cloud environments.">
- Knowledge of CSV tools like HP ALM, ValGenesis, or similar.">
- Certification in GAMP 5, CSA, or regulatory compliance frameworks is a plus.">
About Us
">At Archimedis, we are dedicated to delivering high-quality solutions that meet the highest standards of regulatory compliance. Our team is passionate about helping customers achieve their goals through effective validation strategies.
">How to Apply
">If you are a GxP validation expert with a passion for compliance and efficiency, please submit your application. We look forward to hearing from you.
