Posted to MedZilla on 12/15/2018

Randstad Pharma

Quality Assurance 20404-MZ


Quality Assurance Compliance Specialist IV

Position Description

  • Support CAPA development and serve as quality approver
  • Track global CAPA progress and evaluate evidence for CAPA closure
  • Support GPV SOP development and serve as quality approver
  • Ensure inspection readiness in the GPV, Regulatory, and Medical Information areas including SME training/preparation and back room support activities; work with the R&D Audit and Inspection function to analyze risks and develop inspection readiness strategy

Position Responsibilities

  • Coordinate quality inputs for PSMF and partner with GPV team and other quality units to support maintenance and compliance of PSMF on an ongoing basis
  • Collect and monitor compliance metrics globally and evaluate possible trends
  • Contribute quarterly metrics for quality management review
  • Provide consultation to for possible quality issues, lead quality investigations and support completion of root cause analysis
  • Provide input to corporate audit planning
  • Establish partnership with corporate and affiliate quality units as needed.

Position Requirements

  • 9+ Years of Experience
  • Quality, processes, and compliance oriented
  • Knowledge of GVP, government regulations and guidelines (EMA, FDA, PMDA) pertaining to pharmacovigilance
  • Solid knowledge of IT structure and Information Database Systems (such as Oracle Argus,Trackwise)
  • Ability to write standard operating procedures
  • Ability to manage multiple projects and priorities
  • Bachelor's degree in life science required. (PhD or PharmD preferred)

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