Ergomed

Pharmacovigilance

QualitySpecialist,Deviations&CAPAs

$110–165k ~AI est. Warsaw, Masovian Voivodeship, Poland FULL TIME
The Brief

“Quality Specialist, Deviations & CAPAs at Ergomed. Skills: Deviations, CAPAs, Quality Assurance. Lead the administration, tracking and management of Devs. Support Subject Matter Experts to conduct root cause”

Industry & Context.

Pharmacovigilance
Problems you'll solve

Root cause analysis

What They're Looking For.

Must Have

Prior experience in a Quality and/or Compliance role is required, University degree in Biomedical sciences, Natural sciences or Health Sciences is required, MS Office, particularly advanced skills in Excel and Word

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.

Lead the administration

tracking and management of Devs

Support Subject Matter Experts to conduct root cause

Lead Devs and CAPAs through the workflow

Provide support to operations

Act as subject matter expert on process of

Participate in audits and inspections

Support team management

Prepare metrics on procedures and trainings for internal

How You'll Work.

Team & Collaboration

Subject Matter Experts; Operations team; Quality and Compliance team

Free ATS check

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