Job Summary • The NextGen eQMS Implementation Specialist will support the global roll out of a new electronic Quality Management System (QMS), from preparation, through Go-Live and post implementation support “hyper-care”. • The system will be implemented across multiple business units and countries in the wider Healthcare organization. • You will be working with a dynamic cross-functional team for the global roll out. • The team includes IT, product managers, quality and compliance professionals. • You will be a key player in the delivery of this new system.
Responsibilities: • Liaise between central project team and local team. • Responsible for data gathering in preparation for go-live. • Responsible for managing training with regional/local teams. • Act as Qualified Trainer to support local/regional training. • Act as Point of Contact to monitor, report, and escalate user applications issues and ensure these issues are formally logged. • Support development of local training (if required). • Support development & validation activities of eQMS modules (if required). • Adhere to quality standards, policies, and procedures in alignment with regional/local regulatory requirements and industry guidelines.
Qualifications: • Pharmaceutical and/or healthcare industry experience – Preferred • Italian, Polish, French, German, Portuguese or Spanish level request: intermediate - Preferred • Bachelor's degree or International equivalent in Science related field – Preferred • Experience with electronic Quality Management Systems, with knowledge of GxP such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) • Intermediate-advanced computer skills: Word, Excel, and Outlook (Microsoft Office) • Excellent verbal and written communication skills • Ability to work in a fast-paced environment
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