This role will have a specific focus on the archival solutions, including the electronic archiving application and Liverpool records room. Provides support to business processes, procedures, and execution of the Global Document Archival System.
This role will provide support to the maintenance of global quality systems processes, procedures and operational activities which includes, but is not limited to Archival, Document Retention, Document Management, training around archival system design and application of Global Quality Policies & Standards. This role will support key stakeholders to ensure compliance of Seqirus programs to phase appropriate GxPs, global legal/regulatory requirements and applicable global Seqirus Quality Policies.
Responsibilities:
Support improvement efforts and on-going maintenance of Archival Systems by identifying gaps and supporting the implementation of improvements.
Drives adoption of Archival System across the enterprise.
Support site and function audit preparations with respect to e-Archive functionality.
Support development of harmonized training for Archival System.
Performs as contact for technical questions relating to the business processes and use of Archival System.
Supports change controls related to Global Document Archival System.
Support development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and usage of archival systems.
Support the development of training for archival systems.
Maintain system related metrics.
Support system improvement initiatives to optimize the business processes and practices for archival systems.
Provide high quality customer service and first line archival systems support.
Interface with other Seqirus and CSL Quality functions to share best practices and identify / leverage opportunities across Quality systems and processes.
Support site and function audit preparations with respect to document archival.
Own investigation of deviations and CAPAs related to archival systems.
Support change controls related to archival systems.
Required:
Bachelor’s degree in scientific discipline/Life Sciences preferred or equivalent experience in biotech or pharmaceutical industry.
Experience in a GxP regulated environment within the industry, or equivalent.
Preferred:
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