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.
- Minimum of a college or university diploma. Equivalent experience may be considered.
- 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 email@example.com