Auditor

Responsible for the conduct and delivery of assigned audits and audit CAPA management on behalf of Arriello clients. Working alongside the assigned PM for the delivery and satisfaction of client needs. Working closely with the Manager of Audit & Quality Assurance (A&QA) executing client required quality activities and supporting any A&QA efficiency needs. Client relationship management is paramount to this role.

What will be your key responsibilities:

Audits/Inspections

  • Conduct/manage third party audits on behalf of Arriello Pharmacovigilance (PV)
  • Conduct external audits on behalf of Arriello
  • Train other auditors in auditing best practise
  • Manage the Arriello internal, vendor and Client audit programme’s as requested
  • Act as an Audit co-ordinator/PM for audits conducted on behalf of Arriello by consultant auditors (as required)
  • The writing and review of Audit reports and CAPA response documents
  • Cooperate and communicate with relevant departments, clients and vendors in regards to A&QA matters
  • Responsible for inspection readiness programs (as requested)
  • Approval of Audit CAPA evidence on behalf of clients
  • Responsible for the development and management of project specific procedures in regards to audits
  • Drafting of audit strategies as required
  • Creation of audit schedules as required


Deviations

  • Responsible for Deviation CAPA management on behalf of our clients as required


Vendor Management

  • Responsible for the link between vendor management and audit management for our clients as required
  • Responsible for setting up vendor management programs on behalf of our clients as required
  • Responsible for the development and management of project specific procedures in regards to vendor management as required


Other administrative activities

  • Maintenance of the Quality Management System on behalf of Arriello clients
  • Procedural report writing
  • Marketing support for A&QA
  • Ensure that standards and other applicable regulation are followed by processes developed in the company, identify needs for improvement of current processes
  • Ensure proper data retention and archiving of all documents used in the A&QA department


Key responsibilities:

  • Building relationships with external clients
  • Execution of activities with high quality and timely manner;
  • Effective time management and professional cooperation with internal and external partners based on transparency trust and clear communication
  • Client facing role
  • Deliver quarterly company expectations
  • Timesheet management
  • Financial management of projects as required

What experience should you have:

  • GVP Auditor – essential (2years minimum)
  • Operational PV background (3 years minimum)
  • University degree.
  • Ability to manage multiple/complex tasks and challenging timelines.
  • Working knowledge of tools, methods, and concepts of quality assurance.
  • Solid knowledge of relevant regulatory standards.
  • Excellent data collection and analysis skills.
  • Strong attention to detail.
  • Fluent English, both oral and written
  • Excellent communication skills Excellent computer skills,
  • Ability to work in a multi-cultural environment
  • Able to people manage, inspire and set example for junior members of the team.
  • Customer focus

What do you get in return:

  • 5 weeks holiday plus national holidays in your given location
  • 3 personal days
  • Flexible benefits, based on location
  • Home office stipend
  • Annual bonus program
  • Other employee Bonuses (spot bonuses and employee nominated bonuses)
  • Dog friendly offices
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