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Documentation Specialist

  • Salary: Negotiable
  • Job type: Contract
  • Location: Waterford
  • Sector: Science
  • Date posted: 14/03/2018
  • Job reference: J383254A

Documentation Specialists

My client, a global life science leader is currently seeking several Documentation Specialists to join their team. In this role you will be working in a GMP environment to ensure GMP requirements are met. This is a contract opportunity within a world leading organisation.

Key Responsibilities

  • Define, manage and maintain a documentation control system for all site cGMP Documents
  • Manage, index and control the on-site and off-site archive to meet cGMP needs.
  • Create and maintain procedures on site for Documentation Record Control & Retention and Architecture, Format & Content.
  • Train all site personnel on the Documentation Management Processes.
  • Conduct all activities in a safe manner and report all safety issues and/or concerns
  • Attends team meetings, regular 1:1's, support owns goals and team goals and actively manages own performance development.
  • Define, manage and maintain key metrics for Site Documentation ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities
  • Compliance Related Tasks
  • Ensure issuance and storage of documents
  • Participate in internal audits, support all external audits and any key quality initiatives
  • Support and report right first-time documentation findings to support continuous improvement initiatives
  • Ensure continued site wide compliance with the documentation control process
  • Supporting and providing appropriate information to support Product Performance Reviews (PPR)

Experience and Education

  • Documentation background
  • Leaving Certificate or equivalent and will preferably have secretarial and/or clerical qualification or accreditation
  • Third level qualification (science or related discipline would be an advantage)
  • Minimum of 2 years' experience in a similar role

Skills & Knowledge

  • Very good knowledge of cGMP in a regulated environment
  • Strong Planning/Organising skill
  • Working knowledge of computer systems
  • Personal development and goal management skills
  • Project Management skills and experience a distinct advantage

For additional information on this or similar positions, please contact Kathryn on or call 016455244

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