QA Documentation Specialist

  • Contract
  • Dublin

Website Ref: TPM04149

Summary:
A QA Documentation Specialist is required for a biopharmaceutical company in North Dublin. This role will be responsible for supporting the Quality Department in the management of the site GMP documentation, and in support of the Quality functions in various administrative duties. Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Supporting the management of the site Documentation / SOP management systems.
  • Provides compliance contribution to project teams and leads specific projects.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Responds to non-standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
  • Presentation, compilation and review of data as directed.
  • Act as Assistant to Head of Department (part time) with associated diary management activities.
  • Scheduling, coordinating and monitoring appointments for department managers and Leads.
  • Management of purchase orders and associated activities related to budgets.
  • Monitoring of department training due dates in Learning Management System (LMS).

Qualifications & Experience:

  • Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent.
  • A minimum of 3-4 years experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations.
  • Knowledge of EU/US quality related pharmaceutical regulations.
  • Basic computer literacy.
  • Strong communication skills.
  • High level of technical aptitude & motivation.
  • Good presentation skills.
  • Excellent knowledge of relevant Quality and GMP Compliance Guidelines.

To apply for this job email your details to patricia.arrue-elorza@Tandepm.ie.