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QA Document Control Associate

Job description

My client is a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. This role requires a high level of initiative, energy and motivation as well as organizational skills.

The role as a QA Document Control Associate would see you reporting to the Quality Systems Team lead and maintaining functional responsibility for oversight of Site Documentation, Documentation system and Archive activities in a cGMP regulated environment.

 Responsibilities- But not limited to: 

  • Oversee all aspects related to controlled document mastering, issuance, distribution and storage in a GxP environment, including Commercial and Clinical batch records, SOPs and forms.
  • Maintain technical agreements with external service providers.
  • Maintain technical reports.
  • Perform routine internal audits to ensure compliance and continuous process improvement.
  • Oversee employee training on GDP and the electronic document system.
  • Coordinate external document storage activities and maintain related contracts.
  • Other duties as assigned.

 Education

  • Minimum of a college or university diploma. Equivalent experience may be considered.

 Experience

  • 5+ years experience in a cGMP regulated manufacturing environment with exhibited knowledge or proficiency in Document control and related systems
  • Good knowledge and understanding of GMP requirements and guidelines
  • Proficiency with technical summary report generation required, with exceptional organizational and Computer skills preferred.

 For more information please call Leah on 021 4847 135 or send your CV to loflaherty@simar.ie