Healthcare QA Specialist

Upcoresolutions

Louisville, KY

JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Communication Skills, Computer Skills, Cross-Functional, Customer Escalations, Data Collection, GMP (Good Manufacturing Practices), German Language, GxP, Healthcare, Italian Language, Manufacturing, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Word, Polish Language, Portuguese Language, Presentation/Verbal Skills, Product/Service Launch, Quality Assurance, Quality Management, Quality Metrics, Regulatory Requirements, Sales/Support Engineering (SE), Spanish Language, Training/Teaching, Writing Skills
LOCATION
Louisville, KY
POSTED
13 days ago

Our client is looking for - 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 UPS 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

About the Company

U

Upcoresolutions