Responsibility for Global and Local Computerized system (Computerized system technical owner), adequacy, maintenance and validation activities. Compliance to CFR Part 11, annex 11.
Provide quality support and guidance to operation, qualification, validation, monitoring and maintenance of Critical Systems as Purified water, HVAC systems, Process gases as Nitrogen, air etc.
Environmental monitoring
Data Integrity
SOP’s
External and Internal audits
API shipments monitoring
Employees qualification and Training
Handle supplier quality management, including supplier qualification and evaluation, Quality agreements and conducting supplier quality audit