Roles and Responsibilities
Ensure compliance with US FDA regulations (CFR Title 21 Part 11) through system support, CSV management, and IT compliance activities.
Provide technical expertise on SAP systems to maintain data integrity and accuracy.
Collaborate with cross-functional teams to identify and resolve issues related to document control, change control, and deviation management.
Develop and implement effective solutions for process improvements in quality assurance processes.
Conduct audits and inspections to ensure adherence to regulatory requirements.