GxP Records Archivist

The Archivist

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 life cycles. Documentation is correctly classified, indexed and retained compliantly according to required retention periods, and compliance with EU GMP, data integrity, biosafety, HSE, BI Global/Local SOPs and EU Directive 2001/82/EC is maintained.

This is a Fixed‑Term & Part‑time role (3 days a week) until December 2027.

• Ownership & management of local procedures related to the archive.
• Regular archiving of GxP documents.
• Manage entry/retrieval of documents.
• Ensure access control, safekeeping and key control.
• Identify key archiving attributes and support record retention assignment.
• Orchestrate the document reconciliation process.
• Ensure orderly storage of records.
• Control/document movement of records.
• Conduct periodic spot checks of retrieval time.
• Maintain stock of archiving consumables.
• Destroy records after the retention period.
• Retrieve documents timely for audits/inspections.
• Continuously improve the archiving process.
• Train individuals and users in true copy generation and archiving.

• Manage storage/retrieval of documents to an off‑site facility.
• Manage annual purchase orders.
• Oversee destruction of records after the retention period.
• Act as SME for external archive audits (e‑DMS Archivist).
• Move obsolete/retired documents to the archive folder in VQD and delete them at the end of the retention period.

• Ensure audit/inspection readiness.
• Organise and prepare documentation for audits/inspections.
• Participate and support during regulatory inspections, global quality audits and internal audits.

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 is beneficial.

• Knowledge and experience of GMP, data integrity, documentation management.
• Ability to assess and understand large volumes of records.
• Good IT skills, including databases.
• Excellent organisation and prioritisation.
• Strong attention to detail and 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.