QA Doc Controller

Purpose of Job

• 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.

Major Activities

• Perform daily administrative tasks for the MasterControl System, including, but not limited to:
  1. User Management
  2. Document Review, Approval & Release
  3. Reviewing Batch documentation
  4. Setup and maintain training courses and curriculum
  5. Workflow Management
  6. User Support
  7. eQMS and Document support during Regulatory, Competent authority and Third-Party audits.
  8. Issuance of Batch Manufacturing Records and Batch Numbers.
  9. Hard Copy Document Retention and Archiving.
  10. 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.

Key Performance Indicators

• 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 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

Key Job Competencies

• 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

Job Background

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