Maintain the Documentation Management System (eDMS) as the System Administrator for the Affiliate and support the JAPAC region as required.
Act as System Administrator for the Quality eLearning Management System (eLMS)
Ensure training curriculums are established and maintained within eLMS and regularly reviewed with cross-functional leaders.
Integration of local quality regulations for drugs, biologics, devices, and/or combination products and cosmetics.
Design effective quality systems, procedures and/or processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality systems.
Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
Plan, prepare, review, and approve quality documentation such as change controls, product reviews and other local requirements.
Support self-inspections, and internal, external and MoH audits as directed by the manager.
Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.
Monitor metrics and KPIs to ensure compliance.
Support the Management Review process for the affiliate
Qualifications
Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire and OneVault.
Excellent computer skills, including Microsoft Office and Visio
Strong written and oral communication skills
Good time management skills
Full understanding of local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products and cosmetics.
General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations.
Ability to support projects as a team member as assigned by manager.
Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
Make decisions in collaboration with management.
Acts as an owner - use available resources to independently complete assigned tasks.
