QA Document Controller - FTC 9 Months

*QA Document Controller - FTC 9 Months*
*Job Title:* QA Document Controller - FTC 9 Months
*Location:* London
*Job Type:* 9 month contract FTC
*Job Conditions:* Full Time, 40 hours a week

*Purpose of Job*
Act as the QA Documentation Controller for the business, ensuring that files stored and archived both within the electronic Quality Management System (eQMS; MasterControl) and outside of the eQMS are maintained appropriately according to relevant procedures.
Support validation of the MasterControl system to assure compliance across all sites; supporting project and upgrade re-qualification activities.
Provide first line support to end users for the MasterControl system, providing training as required. Support the Quality Assurance team in other activities where requested.
*Major Activities*

* Perform daily administrative tasks for the MasterControl System, including, but not limited to:

* User Management
* Document Review, Approval & Release
* Reviewing Batch documentation
* Setup and maintain training courses and curriculum
* Workflow Management
* User Support
* eQMS and Document support during Regulatory, Competent authority and Third-Party audits
* Issuance of Batch Manufacturing Records and Batch Numbers
* Hard Copy Document Retention and Archiving
* Organise and manage QA Document Control visibility and activities
* Author and maintain procedural documents related to the management of documents within the QMS
* Maintain documentation held externally from the QMS, including document issue, return and archiving as required
* Support the QMS projects, including partaking in computer system validation activities where required
* Develop and deliver training related to the QMS and any other role related training as required
* Support Periodic System Reviews as required
* Provide Key Performance Indicator Reports for departments as required
* Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
* Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
* Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state
*Job Background*

* Minimum of 3 years experience working in a GxP environment
* IT literate, experience managing and operating an electronic QMS
* English language required