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Consultant Csv/gxp Auditor (Australia/apac)

Zigzag Associates Ltd - Australia,

Health, Medical & Pharmaceutical
Source: uWorkin


We are looking for a Consultant Quality Assurance Auditor, with CSV and an additional GxP (GCP, GLP, GMP), to provide a variety of QA services to external clients across the Australia/APAC region. You will conduct contracted activities in accordance with contractual requirements, regulations, guidelines, and standard operating procedures (SOP's).

Client/project-related activities

  • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
  • Conduct technical peer reviews and provide feedback on client deliverables
  • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
  • Provide strategic advice to clients on Quality Management System development and change
  • Provide a consultancy service for CSV/GxP and/or additional regulations
  • Develop and deliver training programs and/or materials
  • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
  • Keep Zigzag’s relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
  • Foster and maintain good, professional working relationships with clients and identify new business opportunities
  • Assist with the preparation of proposals and presentations to prospective clients

Skills Required

  • Thorough knowledge of GxP and/or other applicable regulatory requirements
  • Excellent attention to detail, organisation, and prioritisation skills
  • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
  • Self-motivation and ability to function independently and within a team
  • Ability to function calmly under pressure
  • Practical and enquiring approach to problem-solving
  • Dedication to quality and reliability in all aspects of work
  • Responsiveness to customer needs and focus on customer satisfaction

Education or Equivalent Experience

  • Life science degree or equivalent qualification or experience preferred
  • Extensive auditing experience in CSV, and ideally an additional GxP area

Although our positions are remote, due to travel restrictions, the successful candidate MUST be based in Australia.