Your mission
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.
Job Description
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 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
Why us?
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