Hobson Prior are currently looking for a QA Document Controller to join a fantastic biotechnological organisation on a fixed-term contract basis located in London. Our client is focused on producing potentially curative treatments for patients who live with serious illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• The ideal candidate will be responsible for performing everyday administrative tasks for the MasterControl System.
• 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.
• 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.
• 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.
• 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.

Key Skills:

• Excellent interpersonal skills.
• Good organisational and time management skills and able to demonstrate flexibility and adaptability.
• Good attention to detail for data entry tasks and understanding of Good Documentation Practices.

Requirements:

• 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
• Experience working with high volumes of documentation, electronic and paper.
• 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.