Major Activities

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

• Maintain documentation held externally from the QMS, including document issue, return and archiving as required
• Act as owner and SME for specific processes/systems within QA Document Control, e.g. Training, Document Archiving, Retention and reconciliation.
• Maintain documentation held externally from the QMS, including document issue, return and archiving as required.
• Develop and deliver training related to the QMS and any other role related training as required
• Provide Key Performance Indicator Reports for departments as required.
• Maintenance of reconcillaition process for the printed controlled copies on the QMS and outside.

• Documentation maintained outside of the MasterControl system is maintained in an easily retrievable state
• Any records overdue as 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
• All users are appropriately trained with accurate training currciulums 

Key Job Competencies

• Experience in working with electronic Quality Management Systems for document and process management and reconciliation
• 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 maintaining end user training curriculum, 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
• Experience and knowledge of working in a regulated environment, specifically with regards to record retention and reconciliation
• 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 is closed timely and in a RFT state
• Able to perform Document Controller activities when required for printing and issuance of Controlled copies 

Job Responsibilities

• No direct reports 

Job Background

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