The administrator is responsible for supporting, administering and maintaining a variety of documents required for the Quality Management, Customer Service and General Administration functions. This contract position is based in Dublin and reports to the Quality Director.
This role gives an opportunity for an individual to further develop their career path by being exposed to many varied experiences in a fast-moving dynamic environment.
- The Quality Management Systems (QMS) ensure the company adherence to Quality standards and Regulatory requirements for their commercial and development products/projects which encompass Combination Drug-Medical Devices, small and large molecule products.
- The Customer Service function ensures that our customers throughout the rest of the world receive their orders on time according to their requirements. To get products delivered in a timely/compliant way, several key freights, regulatory, quality and financial documents are required to accompany the shipment.
- This position provides tactical management of Quality Assurance and Customer Service activities, collaborating with cross-functional team members, contract manufacturer partners and other external service providers.
? Documentation management, including processing, distribution and filing of all documents associated with quality and drug safety.
o Initiation of change requests for new and amended documents.
o Routing of controlled documents through the approval and implementation process.
o Issue and maintenance of controlled documentation.
? Manage, control, and publish QMS metrics and KPIs with input from other Quality team members
? Track and maintain various QMS systems at the direction of the quality director
? Work with the rest of the quality team to interrogate these systems for information
? Track the status of various activities for quality agreements, related contracts, and documents
Secure and collate documentation required for product shipments by liaising with QA/RA/SC departments and related external partners e.g. CMOs/Freight Forwarders/Customs Brokers
- Act a key person in the documentation / correspondences keeping, tracking, handling circulation and distribution across the team QA/ RA/ SC
- Assist with Freight logistics documentation
- Support documentation for notarisation/legalisation by liaising with couriers, embassies and chamber of commerce.
- Store both hard and soft copies of all documents
- Support in document correspondence preparation and transmittal/ sending
- Control Documentation uniformity (template, reference, version no etc.)
KNOWLEDGE AND SKILL REQUIREMENTS:
- Minimum of 2- 3 years' experience working within a QA (GMP/GDP) function in the healthcare, pharmaceutical sector or another regulated Industry.
- Experience working with document control systems
- Demonstrated understanding of criticality of attention to detail, data accuracy and document control
- Must have the ability to communicate effectively with management and fellow peers
- Excellent Microsoft Office skills and an ability to work independently across different departments.
- Excellent organisational skills