Quality Assurance Consultant job – Foresight Group International AG – Parsippany, NJ

Quality Assurance Consultant

Foresight Group International AG

5 reviews


Parsippany, NJ

Location

Parsippany, NJ

Job Type

Full-Time Regular

Job Description

Quality Assurance Consultant

At Foresight Group, there are endless opportunities to take what you know, develop your skills, and grow with a group that takes on the world’s toughest challenges as they relate to complex business process, compliance and safety system issues that exist within pharmacovigilance/drug safety operations.

If you feel qualified for this role and would like to be part of a company where people love what they do and enjoy making a difference to improve the safety of people around the world, we welcome you to apply!

Role Summary

Involved in the maintenance, management and administration of the company’s Quality Management System ( QMS). Facilitate and manage related activities for client requested audits of Foresight Group. Conduct internal audits to ensure compliance with the QMS. As needed, provide guidance to project teams on computer system validation and regulatory compliance.

Job Duties- to include, but not limited to:

  • Quality Coaching – Coach employees on regulatory compliance, quality practices and the Foresight QMS ( In-person, by video conference, WebEx, and or teleconference)
  • Quality Reviews – Perform reviews of project deliverables, training materials, sales proposals, etc.
  • Auditing ( Internal, External, Facilitation) – Prepare documentation for auditor examination, coordinating resources, respond to audit findings ( if any), and manage remediation efforts ( if any) to closure.
  • Development/Refinement of QMS documents – Participate in writing Standard Operating Procedures ( SOP’s), working practices, business process improvement, etc.
  • Provide QMS training

Education and Other Qualifications

  • Bachelor’s Degree or higher
  • Previous Quality Assurance and Computer System Validation experience, ideally with Drug Safety Systems.
  • Technical Writing ( Strong Microsoft Office skills)
  • JIRA experience is very helpful
  • Ability to be client-facing and effectively lead discussions and presentations
  • GAMP5 familiarity, including the V-Model, System Classification, and Criticality Assessments
  • Has previously served in a Validation Leadership role on at least 3 Enterprise GXP projects, or 6 smaller divisional GXP roll-outs or upgrade
  • Familiarity in a PV, GCP Safety environment is highly desirable
  • Familiarity with 21CFR Part11 and EU Annex 11 Assessments
  • Familiarity with Defect/Deviation Management and/or CAPA Management

Nice to Haves

  • Agile SDLC experience
  • ISO27001 or SSAE16 SOC1/2 Accreditation
  • Has supported or defended validation during internal and external audits
  • Ability to read SQL code
  • MHRA Data Integrity Assessments
  • Privacy Framework Compliance ( Privacy Shield, ASIP Sante, EU Model Contracts, Safe Harbor)
  • Conducted Vendor Audits

About secureteam

secureteam
A Computer Programmer whose articles got mentions from the likes of The New York Times, Kissmetrics and AllTopStories. He writes articles, novels and poems; spends most of his time reading everything he could get his hands on. He is currently pursuing his Masters from The University of Illinois and holds a Bachelors in Electronics Engineering from the University of California. He is a programmer, a motivational writer and speaker.

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