Responsibilities:
  • Establishes and maintains complex departmental filing and archival systems (both paper and electronic documentation) according to applicable processes and system requirements
  • Assist with management of external audit resources
  • Maintenance of systems and databases used or owned by CQA, as well as the assignment and tracking of departmental trainings, to include serving as department administrator for applicable Learning Management Systems (LMS)
  • Assist with the scheduling, preparation and reporting of internal and external audits
  • Support management of deviations and CAPAs (internal and external)
  • Support development and deployment of Quality procedures and internal training programs and initiatives
  • Support regulatory authority inspection readiness projects as directed, preparation for inspections, on-site logistical support during GXP inspections and coordination of inspection responses
  • Assist with compiling, formatting, analyzing, and reporting quality metrics.
  • Organizes and prepares technical departmental presentations and graphs in Microsoft Powerpoint
  • May represent manager or department at *** meetings and committees
  • Provide support to other tasks and initiatives within R&D QA as directed.
  • 2. Administrative Support
  • Organise domestic and international meetings, teleconference with multi-zone for global CQA Head, CQA Regional Leads or manage their calendar(s)
  • Organise domestic and international travel arrangements
  • Management of expense reports for CQA
  • Provide assistance with meeting organisation, including room bookings, catering requirements and other relevant resources
  • Compiles, formats and archives confidential and non-routine correspondence and documents
  • Scanning/copying of documents
  • Maintaining department directories, calendars and organisation charts
  • Be proactive with issues that arise and impact on business activity and ensure that senior management is notified
  • Manage and track departmental vendor contracts and invoices and may act as primary contact for departmental budget reporting
  • Ability to deal with rapid change
  • Ability to multi task and prioritise work
  • Customer service focus
  • Excellent planning and organisational skills; ability to prioritise and coordinate all aspects of administrative tasks across a large workload
  • Problem solving and analytical skills
  • Effective interpersonal verbal and written communication skills in a cross functional environment, including experience interacting and communicating with Senior Management.
  • Attention to detail
  • Computer literacy
  • Ability to establish credible relationships within and externally
  • High level of punctuality and reliability
  • Ability to work independently and take initiative
×