Document Controller/Archivist

Job Purpose

The Document Controller is responsible for ensuring the effective management, control, and archiving of all site documentation in compliance with GxP guidelines and internal SOPs. This role safeguards the integrity, accessibility, and accuracy of controlled documents and archived records, supporting both operational efficiency and regulatory compliance.

Main Areas of Responsibility

Archivist

Organise and maintain site archives. 

Archive GxP and non-GxP study raw data, study plans, reports, electronic data/records, and any other relevant site documents following the appropriate cataloguing system based on current SOPs. 

Ensure that access to the archive is controlled. 

Ensure the orderly storage and retrieval of records and materials is facilitated by a system of indexing.

Ensure that movement of records and materials in and out of the archives is properly controlled and documented including where applicable off site archiving facilities

Manage and coordinate document transfer of archived data to sponsors when required.

Inform site management of all matters related to the archive as necessary.

Monitor the environment conditions of the archives.

Follow of GxP guidelines concerning archiving.

Write and revise SOPs for Archive Management procedures.

Provide Archiving Management training to users if required.

Document Controller

Manage the process of review of controlled facility documents.

Manage and coordinate internal and external SOP/Policy issuing.

Ensure availability of valid controlled documents.

Maintain a system of indexing to allow for version control and timely review of facility documents.

Submit signed original SOPs to archive.

Write and review SOPs for Document Control processes.

Work in accordance with SOPs by authoring, reviewing, and maintaining SOPs, guidance documents,policies and study documentation, as well as providing training and support to staff.

Format plans and reports to eCTD compliance where applicable

Support the management activities and personnel.

Qualifications & Experience

Previous experience in physical and digital data and document management and excellent Microsoft office skills.

Advantageous to have experience in the pharmaceutical industry, and knowledge of GLP and GCP regulations.

Good knowledge of GLP, GCP and GMP archiving where applicable.

Good knowledge of the IT systems in use.

Strong attention to detail, and excellent typing skills.

Good interpersonal and organisational skills.

PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.