About the role
We are looking for a skilled and experienced Senior Executive – IT with a strong background in the pharmaceutical industry, particularly in GxP compliance, data integrity, GAMP 5, and 21 CFR Part 11. The candidate will be responsible for supporting and maintaining IT systems in a regulated pharmaceutical environment, ensuring compliance with applicable regulatory requirements, and maintaining the validated state of computerized systems.
Key Responsibilities- Manage and support IT infrastructure, applications, and computerized systems in a regulated pharmaceutical environment.
- Ensure compliance with GxP requirements, data integrity principles (ALCOA+), and applicable regulatory guidelines.
- Support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities, as applicable.
- Prepare, review, and maintain validation documentation, including URS, risk assessments, validation protocols, test scripts, traceability matrices, and validation summary reports.
- Ensure compliance with 21 CFR Part 11, including electronic records, electronic signatures, audit trails, and access controls.
- Apply GAMP 5 principles for risk-based validation and lifecycle management of computerized systems.