Required Experience and Skills:
- Atleast 3 years performing in the IT Quality and Compliance and/or data integrity roles.
- Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) and Data Integrity (including MHRA, FDA regulations and guidelines).
- Strong understanding and experience interpreting data integrity regulatory requirements and data governance principles. Evidence of using this knowledge to create training materials /perform effective training of individuals on data integrity/data governance principles and the performance of CSV to ensure data integrity.
- Experience evaluating, designing/redesigning business rules, processes, definitions, quality expectations and checks & balances to ensure data integrity in a scalable and efficient manner.
- Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL.
- Excellent communication skills in Spanish and English, both verbal and written.
- Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment.
- Knowledge of general software and database concepts.
- At least 4 years of experience working in a similar position within a GxP regulated environment
- Familiarity with project management practices
- Experience with risk analysis, risk management and computer system periodic review practices and tools.
- Knowledge of infrastructure technology and platforms.
- The ability to management projects, work independently and with teams at various levels in the organization in waterfall and agile environments.
- Excellent organizational and problem solving skills and attention to detail and accuracy.