Validation Lead

Job Description:
Role : Validation Lead
Location : Cape Town (South Africa)
Experience : 10-14 Years of experience
List of Key focus areas and responsibilities / JD
Computer Systems Validation & Qualification (CSV) (70%)
Manage and process access to laboratory systems and software,
Troubleshoot activities related to computer systems validation, such as root cause analysis, deviations, and system risk assessments.
Execute validation / qualification plans, protocols, and tests for computerized systems.
Manage changes to validated computer systems.
Provide IT Quality Subject Matter Expert (SME) input/execution for any actions stemming from CAPAs, NCRs, and CRs that impact lab software and hardware systems
Support internal and external audit activities related to CSV.
Verify testing plans, activities, deliverables, and records, and provide consultancy on test-related deviations and corrective actions according to approved procedures.
Support system periodic reviews
Collaborate with cross-functional teams, including Business Quality and MSAT, to ensure compliance with corporate policies and procedures regarding computer software validation.

Lab Systems Management and Support (20%)
Provide on-site technical support and troubleshooting for laboratory software and hardware systems in both Operations and Development Labs.
Manage and maintain the laboratory software and hardware systems.
Collaborate with laboratory staff to understand their technology needs and requirements.
Assess and implement new technologies and systems to improve laboratory efficiency and productivity.
Collaborate with the local Informatics team to integrate laboratory systems with the overall IT infrastructure.
Provide ongoing support for the AKTA Monitoring Solution in Manufacturing
Security patch management

Project Support and Testing (10%)
Lead the testing of laboratory software in preparation for the Windows 11 pilot rollout