Description
- 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.
Apply