Are you ready to drive innovation at the intersection of technology and healthcare, transforming data into insights that power life-changing scientific breakthroughs?
Proclinical is seeking a Senior IT Analyst to support IT compliance and validation activities within local projects. This role focuses on ensuring adherence to regulatory standards, managing IT processes, and contributing to audits and inspections. You will play a key role in maintaining data integrity and supporting IT infrastructure qualification while fostering collaboration across departments.
Responsibilities:
1. Act as a subject matter expert for IT compliance and computer system validation (CSV) in local projects.
2. Conduct periodic reviews of local IT systems to ensure compliance.
3. Support IT infrastructure qualification and actively participate in IT change management as part of the quality function.
4. Represent IT processes, including CSV and data integrity, during internal and external audits and official inspections.
5. Manage IT Standard Operating Procedures (SOPs) and coordinate training courses for specialist departments.
6. Serve as the training coordinator for IT-related topics.
Key Skills and Requirements:
7. Background in computer science, law, or a related field.
8. Knowledge of validation project management, preferably within the pharmaceutical industry.
9. Familiarity with GMP, GAMP 5, 21 CFR Part 11, and MHRA guidelines for data integrity.
10. Basic understanding of IT processes and infrastructure.
11. Proficiency in German and English.
12. Strong attention to detail and effective decision-making skills.
13. Problem-solving abilities and a collaborative mindset.
14. High sense of responsibility and accountability.