QA Doc Controller

State purpose of job (1-2 sentences outlining job role).

• 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.

• 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 management of documents within the QMS.
• Maintain documentation held externally from the QMS, including document issue, return and archiving as required.
• Support 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.

• The MasterControl document control system is maintained in a validated state.
• General MasterControl administrative tasks are completed contemporaneously e.g. users are provided with access when applicable, documents are reviewed and approved in a timely manner to facilitate the progression of GxP activities.
• All users are appropriately trained and supported when using the MasterControl Software.
• Documentation maintained outside of the MasterControl system is maintained in an easily retrievable state.
• Any records overdue are escalated appropriately to facilitate progression.
• Attend any required training as defined by line manager.
• Metrics Reports are accurate and provided in a contemporaneous manner as required.

• Experience in working with electronic Quality Management Systems for document and process management.
• Fully computer literate, proficient with standard software packages on an advanced level (such as Microsoft applications, specifically Excel, Word, PowerPoint) and adaptable to new software packages / web applications.
• Experience in developing and delivering end user training, preferred system training.
• Excellent interpersonal skills.
• Good organisational and time management skills and able to demonstrate flexibility and adaptability.
• Experience working with high volumes of documentation, electronic and paper.
• Good attention to detail for data entry tasks and understanding of Good Documentation Practices.
• A basic understanding of computer system validation in the pharmaceutical sector.
• Experience and knowledge of working in a regulated environment, specifically with regards to record retention.
• Knowledge of GCP and GMP with regards to QMS activities.
• 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 are closed timely and in a RFT state.

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