Ergomed
pharmacovigilance
QualitySpecialist,Deviations&CAPAs
“Quality Specialist, Deviations & CAPAs at Ergomed. Ensure Deviations and CAPAs are completed accurately and timely. Manage Deviations and CAPAs in compliance with regulations”
Industry & Context.
What They're Looking For.
Must Have
Prior experience in a Quality and/or Compliance role is required
Nice to Have
Previous Pharmacovigilance (GVP) experience is desirable, Previous Clinical (GCP) experience is beneficial, Prior experience in Medical Information, Medical Devices or IT is desirable but not required, Experience of using an electronic Quality Management System desirable but not required
What You'll Do.
Ensure Deviations and CAPAs are completed accurately and timely
Manage Deviations and CAPAs in compliance with regulations
and management of Devs and CAPAs
Support SMEs to conduct root cause analysis
Lead Devs and CAPAs through workflow
Provide support to operations
Act as subject matter expert on process
Participate in audits and inspections
Support team management
Prepare metrics on procedures and trainings
How You'll Work.
Communication Scope
Fluent in English
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