Data Integrity Engineer, Pharmaceutical

🕒 August 22

đŸ‡«đŸ‡· France – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

đŸ‘·đŸ»â€â™€ïž Engineer

đŸ‘» Ghost score 12%

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đŸ—ŁïžđŸ‡«đŸ‡· French Required

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Logo of Capgemini

Capgemini

10,000+ employees

Founded 1967

đŸ’Œ Consulting

đŸ„ Healthcare

📩 Logistics

Consulting ‱ Healthcare ‱ Logistics

Capgemini is a global leader in partnering with businesses to transform and manage their operations by harnessing the power of technology. With expertise across a wide array of industries such as aerospace, automotive, banking, and healthcare, Capgemini provides a constantly evolving portfolio of services to meet the ever-changing needs of their clients. Their offerings include cloud, cybersecurity, data and artificial intelligence, and enterprise management, among others. Capgemini also emphasizes innovation and sustainability, helping companies achieve digital transformation while promoting environmental and social responsibility. Additionally, Capgemini provides career opportunities across various levels and professions, encouraging innovation and diversity in its workforce.

📋 Description

‱ Deploy and enforce Data Integrity requirements in accordance with ALCOA+ principles and regulatory guidelines ‱ Assess processes, computerized systems, and documentation practices to identify data integrity risks ‱ Conduct or contribute to risk assessments, data audits, audit trail reviews, and remediation plans ‱ Participate in the qualification and validation of computerized systems alongside Quality, IT, Production, Laboratory, and Validation teams ‱ Analyze deviations and nonconformities, lead investigations, and define CAPA actions ‱ Contribute to the preparation for and follow-up of regulatory inspections and internal or external audits

🎯 Requirements

‱ Engineering degree, master’s degree, or equivalent education in pharmacy, quality, industrial IT, biotechnology, life sciences, or a related field ‱ Experience in a pharmaceutical, biotechnology, or highly regulated environment ‱ Strong knowledge of GMP and ALCOA+ principles ‱ Understanding of computerized systems, electronic data, and their lifecycle ‱ Knowledge of GMP Annex 11, 21 CFR Part 11, GAMP 5 guidelines, or Data Integrity guidance is an advantage

đŸ–ïž Benefits

‱ Remote work agreement in France and internationally ‱ Commitment to equal opportunities, parenthood, work-life balance, and sustainable mobility ‱ Open access to certifications and training ‱ Personalized support from your career manager ‱ Nine-month onboarding program ‱ Employee share ownership plan ‱ Preferential rates for activities and services ‱ Reimbursement of sports or cultural membership fees ‱ Inclusive, multicultural, and disability-friendly workplace culture ‱ Community initiatives with partner organizations ‱ Initiatives aimed at reducing environmental impact

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