Senior Computer System Validation Specialist
Há 6 dias
We are seeking a skilled and experienced Computer System Validation (CSV) Consultant to join our team in the Life Sciences sector. The ideal candidate will have experience in the validation of Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS). This role will be critical in ensuring compliance with regulatory requirements and maintaining the integrity and reliability of computerized systems.
Your Key Responsibilities- Conduct thorough risk assessments and impact analyses to ensure compliance with regulatory requirements.
- Validate Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS) to ensure their integrity and reliability.
- Develop and implement efficient validation strategies to minimize downtime and ensure business continuity.
- Provide guidance and support to cross-functional teams to ensure compliance with regulatory requirements.
- A minimum of 3 years of experience in Computer System Validation (CSV) within the Life Sciences industry.
- Proven experience with MES and LIMS systems, with knowledge of regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
- Strong analytical and problem-solving skills, with excellent documentation skills and attention to detail.
- Good command of English and excellent communication skills.
At Capgemini, we value diversity, equity, and inclusion. We believe in creating a work environment that allows everyone to thrive and grow. We offer a range of benefits, including hybrid work arrangements, access to training and certifications, and opportunities for career growth and development.
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Computer System Validation Specialist
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Lisboa, Lisboa, Portugal Capgemini Tempo inteiroWe are seeking a skilled and experienced Computer System Validation Specialist to join our team in the Life Sciences sector. The ideal candidate will have extensive experience in the validation of Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS).About the RoleThe Computer System Validation Specialist will be critical...
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