Data Integrity Expert

Join the professional team of the 120-year-old Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region!

As a supportive company,  we offer to our colleagues a broad spectrum of health and well-being services as well as proprietary facilities for leisure time and recreation. Richter employees and their families may enjoy our holiday resorts, sports fields, swimming pools, kindergartens, doctor's offices, and we also provide comprehensive health screening every two years.

Gedeon Richter is looking for a committed and experienced professional for the position

Data Integrity Expert

Job description

• Manage and drive data integrity and data governance requirements across the Company including Operations, QC, IT and QA Systems
• Lead the Data Integrity activities at Gedeon Richter
• Establish, maintain data governance and data integrity policies, procedures
• Develop and deliver training programs for company staff on data integrity compliance
• Generate and perform data mapping processes, evaluate computerized systems and criticality assessments in conjunction with QRM
• Establish a firm understanding of Gedeon Richter IT infrastructure, lead validation of computerizes systems, assess proposed changes for Data Integrity implications, and recommend changes to enhance Data Integrity
• Conduct data integrity audits, identify gaps and propose solutions
• Provide feedback to department owners on the status of data governance projects and support stakeholders in the mitigation of DI risks
• Be current with regulatory requirements (EU, FDA, ANVISA etc.) and process a working knowledge of the documentation lifecycle Management in accordance with and all applicable regulatory requirements
• Represent Gedeon Richter in regulatory Audits and Self Inspections
• Track and provide Data Integrity metrics to Quality Management

Expectations

• Qualifications Degree in computer science, pharmaceuticals, chemistry or biotechnology, or equivalent experience
• Professional experience: at least 5 years of work experience in data integrity, pharmaceutical regulatory affairs or quality assurance, preferably in a pharmaceutical environment
• Regulatory knowledge: Knowledge of pharmaceutical quality management systems and data management standards, including GMP, FDA 21 CFR Part 11, and EU Annex 11 regulations
• Skills: proficiency in data analysis, validation and problem solving
• Language skills: Fluency in English required to understand international regulations and communicate with foreign partners
• Communication skills: Excellent written and oral communication skills in drafting and communicating technical documentation and regulatory requirements in a clear and understandable manner

Nice to have

• Knowledge of international data security standard (e.g. ISO 27001)

We offer

• Great opportunity for professional development in an innovation driven department
• Great reputation at a well established pharmaceutical firm
• Stability and a trustworthy workplace
• Work in multidisciplinary teams
• Training and development opportunities
• Medical services and life insurance
• Various sport and health opportunities
• Excellent work life balance

The Richter community is looking forward to your application.