ERGOMED

Quality Assurance Officer

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Qatar

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About the role

  • Supports PrimeVigilance functional teams during the pre-audit, audit, and post-audit stages for audits by clients or by PrimeVigilance internal QA function
  • Hosts onsite and remote audits
  • Provides support for regulatory inspections of clients
  • Assists in scheduling client requests for audits/inspection support
  • Supports Quality in the tracking of audit status and deliverables
  • Supports Quality in the compilation and reporting of metrics and KPIs
  • Collects and collates data from systems and sources
  • Authors reports and summaries
  • Supports Quality in the tracking of Deviations and CAPAs
  • Facilitates CAPA response and resolution
  • Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs
  • Supports the PrimeVigilance Senior Leadership team as needed.
  • Supports other Quality activities as needed.

Requirements

  • University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or equivalent advanced degree with pharmaceutical industry experience.
  • Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare
  • Thorough understanding of the principles of Quality Assurance
  • Knowledge of national regulations and guidance related to Pharmacovigilance and Medical Information
  • Experience of participating in audits and inspections
  • Excellent communication and facilitation skills within a global organisation
  • Proactive and self-motivated
Benefits
  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality AssurancePharmacovigilanceMedical InformationCAPASOPsOGsdata collectionmetrics reportingKPI trackingaudit participation
Soft Skills
communicationfacilitationproactiveself-motivated
Certifications
University degree in Biomedical sciencesUniversity degree in Natural sciencesUniversity degree in Health SciencesNursing degreePharmacy degreeBS/Master’s degree in a scientific discipline