Quality Specialist – Document Control
Contract duration: 12 months
Location: Dublin (5 days onsite)
Pay: €21.24/hour
The role holder will join the Document Control Team and, along with other team members, will act as a key point of contact and provide cross-departmental support for a variety of document management systems and processes.
Key Duties and Responsibilities:
• Preparation and issuance of controlled documentation to support manufacturing and testing activities
• Development and maintenance of the Documentation Management System
• Provision of training and user support for the Document Management System
• Management of the Document Archive and Record Retention Systems
• Maintenance of other document systems and processes e.g. SharePoint, Periodic Review tracking.
• Delivery of GMP/GDP training
• Participation in the internal and external audit program
• Collection of quality metric data
• Support completion of investigation/CAPA activities as applicable to role
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements
• Authoring, review and approval of QA-related procedures
Qualifications, Knowledge and Skills Required:
• The successful candidate will hold a BSc in life sciences/pharmacy or similar
• A minimum 1-2 years' Quality experience in a pharmaceutical environment is adventitious
• Working knowledge of cGMP requirements for manufacturing and/or systems and compliance.
• The candidate must be able to work across a team matrix in order to meet accelerated timelines
• The candidate must be able to reprioritise tasks as required to meet changing demands.