Job Reference: J5634532
Updated On: 15/03/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a QMS Documentation Controller & GxP Archivist to join a leading biopharmaceuticals company based in the Wiltshire area. As the QMS Documentation Controller & GxP Archivist you will be responsible for the administration of documentation within the EQMS System guidelines and you will be providing a variety of Document Control functions / services, including document creation, formatting, scanning and controlled distribution of documentation.
Key Duties and ResponsibilitiesYour duties as the QMS Documentation Controller & GxP Archivist will be varied however the key duties and responsibilities are as follows:
1.To manage and maintain the necessary tracking system(s) / database(s) and resolve customers queries and to liaise with internal customers to ensure efficient and effective processing of Quality.
2. You will make decisions on processing Quality Documentation based on content and as guided by SOPs.
3. You will be using computerised systems and will be inputting multiple critical data entries which require a high degree of accuracy, and you will be completing general administration tasks such as filing, stock control, booking meetings etc.
4. As the QMS Documentation Controller & GxP Archivist you will be the first line support, for service users to ensure compliance with defined processes and effective processing.
To be successful in your application to this exciting opportunity as the QMS Documentation Controller & GxP Archivist we are looking to identify the following on your profile and past history:
1. 5 GCSEs or equivalent, including English, Maths and a Scientific subject
2. Proven industry experience in working in an administrative environment using computerised data systems, document control or archive experience.
3. A working knowledge and practical experience with Microsoft Office, including Word and Excel.
Key Words:| GMP | cGMP | Quality Assurance | Sterile | Licensed Medicines | Quality Management System | Change Control | CAPA's | Deviations | Supplier Management | Compliance | Audits | Specialist | Associate | Quality | QA | Batch Release | Documentation | KPI | Manufacturing |administration | CAPAs | SOPs | API | QMS | GxP | Documentation | Document controller
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