The Archivist is responsible to manage all aspects of local documentation archiving across on-site, external and electronic archives. The incumbent ensures documentation, records and information related to GMP manufacturing processes are accurately and securely maintained, accessible, and that data integrity is protected throughout record lifecycles. Ensures documentation is correctly classified, indexed and retained compliantly according to required retention periods, and ensures compliance with EU GMP, data integrity, Biosafety, HSE, BI Global/Local SOPs and EU Directive 2001/82/EC.
This is a Fixed-Term & Part-time role (3 days a week) until December 2027.
Tasks & Responsibilities
- Oversight of Local Archive
- Ownership & management of local procedures related to the Archive.
- Regular archiving of GxP documents.
- Manages entry/retrieval of documents.
- Ensures access control, safekeeping and key control.
- Identifying key archiving attributes & supporting record retention assignment.
- Orchestration of document reconciliation process.
- Ensures orderly storage of records.
- Controls/documentation of movement of records.
- Periodic spot checks of retrieval time.
- Maintaining stock of archiving consumables.
- Destruction of records after retention period.
- Timely retrieval of documents for Audits/Inspections.
- Continuous improvement of Archiving process.
- Training individuals & users in true copy generation and archiving.
- Oversight of External Archive
- Manages storage/retrieval of documents to off-site facility.
- Management of annual Purchase Orders.
- Oversight of destruction of records after retention period.
- Acts as SME for external archive audits e-DMS Archivist.
- Moves obsolete/retired documents to archive folder in VQD and deletes at end of retention period.
- Audits & Inspections
- Ensures Audit/Inspection Readiness.
- Organising and preparing documentation for audits/inspections.
- Participation and support during regulatory inspections, global quality audits and internal audits.
Requirements
- Knowledge of EU GMP, documentation management, archiving & data integrity within GMP environments.
- Education: Minimum three A Levels (or equivalent) at grades A–C including one scientific discipline. Archiving & records management qualification beneficial.
- Knowledge & experience of GMP, data integrity, documentation management.
- Ability to assess/understand large volumes of records.
- Good IT skills incl. databases.
- Excellent organisation & prioritisation.
- Strong attention to detail & accuracy.
- Strong commitment to customer service.
- Clear, professional communication (verbal & written).
- Ability to form constructive relationships at all levels.
- Ability to work independently and in teams.
- Ability to deliver training.
A successful candidate may be asked to undergo a Basic DBS Security Check.
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