- Company Name
- ALERYS
- Job Title
- Spécialiste Data Integrity & Validation des Systèmes Informatisés F/H
- Job Description
-
**Job Title**
Data Integrity & Validation Specialist, IT Systems (M/F)
**Role Summary**
Ensure the integrity of critical data and the compliance of computerized systems with regulatory and internal standards within a pharmaceutical manufacturing environment. Lead validation activities, continuous data quality improvement, training, and support digital transformation initiatives.
**Expectations**
- Minimum 5 years of experience in regulatory compliance, data integrity, and computer system validation, preferably in the pharmaceutical industry.
- Advanced communication skills for training, advising, and collaborating with cross‑functional teams.
- Proficiency in English (minimum B2 writing and speaking).
**Key Responsibilities**
- Define and implement validation strategies for IT systems, ensuring compliance with applicable regulations and internal policies.
- Document validation activities, track non‑conformities, and drive corrective and preventive actions.
- Continuously monitor and assess data integrity risks, analyze deviations, and recommend remediation plans.
- Deliver training and awareness programs on data governance and quality best practices to operational and IT staff.
- Prepare for and participate in regulatory inspections and internal audits, maintaining comprehensive traceability of processes.
- Contribute to digital transformation projects by enhancing tools, methods, and overall system security.
**Required Skills**
- Regulatory compliance (e.g., FDA, EMA, ISO 9001/14001/13485).
- Computer‑system validation (VSI) lifecycle, including risk assessment, test design, execution, and documentation.
- Data integrity principles (access, audit trails, data lineage, segregation of duties).
- Strong analytical, problem‑solving, and project‑management abilities.
- Excellent written and verbal communication, training, and stakeholder‑management skills.
- Knowledge of pharmaceutical manufacturing processes and related IT solutions.
**Required Education & Certifications**
- Bachelor’s degree (minimum 5 years of study) in Pharmacy, Industrial Informatics, Computer Science, or a related scientific field.
- Certifications in data integrity, validation, or quality management are a plus.
- Fluent in English (B2 or higher).