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Career Opportunities in System Validation
1 semana atrás
We are seeking a skilled Computer System Validation (CSV) Specialist to join our team in the Life Sciences sector. Our ideal candidate will have extensive experience in the validation of Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS).
Role OverviewThis role is critical in ensuring compliance with regulatory requirements and maintaining the integrity and reliability of our computerized systems. You will be responsible for conducting thorough risk assessments and impact analyses, as well as developing and implementing effective validation strategies.
Responsibilities- Validate MES and LIMS systems to ensure compliance with regulatory requirements.
- Develop and implement effective validation strategies to maintain system integrity.
- Conduct thorough risk assessments and impact analyses to identify potential risks and mitigate them.
- Ensure that all validation activities are properly documented and maintained.
- Extensive experience in Computer System Validation (CSV) within the Life Sciences industry.
- Proven experience with MES and LIMS systems is essential.
- In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
- Strong analytical and problem-solving skills.
- Excellent documentation skills and attention to detail.
- A multicultural and inclusive team environment.
- A supportive atmosphere promoting work-life balance.
- Career growth opportunities through training and certifications in cutting-edge technologies.
- The chance to engage in exciting national and international projects.
