Quality Assurance Specialist

4 weeks ago


Jersey City, United States Astrix Full time

Our pharmaceutical client is seeking a Pharmacoviligence Quality Assurance Specialist to join their team. The ideal candidate will possess experience using ETQ.


At this time, only applicants local to the Jersey City area will be considered.


Location: Jersey City, NJ

Pay: $40-$45 per hour

Type: Contract


Responsibilities

  • Advise global pharmacoviligence teams on change control of procedural documents before work is started to draft revisions.
  • Review change control documents to ensure Global PV business process owners are considering proper training as a part of the procedural changes.
  • Review and approve procedural documents in ETQ to ensure they meet the needs to ensure quality and compliance and strategically move towards a more lean and efficient procedural document framework governing pharmacovigilance and safety surveillance.


Qualifications

  • Advanced knowledge of end-to-end PV procedural requirements
  • Ability to review/direct PV procedural documents to ensure compliance with international standards and regulations while also promoting a lean and efficient procedural framework.
  • Mid-level understanding of quality management, change control, and quality management systems.
  • Ability to learn and work in ETQ.
  • Advanced ability to work within fixed timelines and manage a high volume of work/multiple projects at one time.



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