Quality Documentation Controller

3 weeks ago

Dublin, Dublin City, Ireland Ipsen Full time

Join to apply for the Quality Documentation Controller role at Ipsen

Join to apply for the Quality Documentation Controller role at Ipsen

WHAT - Summary & Purpose Of The Position

The Quality Document Controller is responsible for supporting the documentation requirements of the Quality department at IMIL and performing Document management activities in the Easidoc Documentation management system.

This position is available on a 12-month fixed term basis, working 30hrs per week.

WHAT - Main Responsibilities & Technical Competencies

  • Administration Management of the Easidoc system: System access, distribution groups, document workflows management , file purging
  • Preparation, distribution and storage of all company documentation that pertain to company compliance with cGMP. Maintain and update the Easidoc electronic documentation system for cGMP documentation. Issue new and revised documentation efficiently and ensure that documentation change is managed according to cGMP
  • Site Technical Expert for Easidoc; Documentation Manager Role, deputy system owner. Perform DocManager tasks in EasiDoc to ensure that revisions to procedures progress through to activation in an efficient manner
  • Delivery of site wide training for Easidoc
  • Issue and reconcile documentation change control requests ensuring that document change is managed according to cGMP
  • Administration Management of specific batch record related data in support of Annual Product Reviews
  • Administration Management (preparation, issuance and reconciliation) of all related Production Batch documentation in accordance with the production schedule
  • Participation during site Internal Audit Programme and area walk downs
  • Administration Management (preparation, review and communication) of departmental, site and Corporate KPl's
  • Administration Management of employee/contractor GMP Training Records
  • Participation in departmental operational excellence initiatives
  • Administration Management Support to the Quality Group

HOW - Knowledge & Experience

Knowledge & Experience (essential):
  • 2 vears administrative experience within an office environment

Knowledge & Experience (preferred)
  • 3-5 years administrative experience within an office environment with experience working with electronic systems for document management

Education / Certifications (essential)
  • Second Level Education, Leaving Cert or equivalent

Language(s) (essential)
  • English
Seniority level
  • Seniority levelNot Applicable
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance
  • IndustriesPharmaceutical Manufacturing

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