QA Document Controller
3 weeks ago
We are currently looking for a QA Document Controller to join a leading Biotechnology company based in the North of the UK. As the QA Document Controller you will be responsible for assisting in the development and on-going management of the companies Quality Management Systems.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Document Controller will be varied however the key duties and responsibilities are as follows:
1. Responsible for the development and implementation of the Quality Management System (QMS), carrying out day to day activities such as CAPAs, deviations, change controls and supplier qualification.
2. Make sure that the CMO batch documentation are compliant to GXP standards, including the review of GMP documentation.
3. You will work closely with the Quality Specialist, and assist in regulatory inspections and customer audits.
4. You will generate, retrieve, manage, and follow-up quality documents generated both internally and generated by vendors in the QMS.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the QA Document Controller we are looking to identify the following on your profile and past history:
1. Relevant degree in a relevant life sciences discipline
2. Proven industry experience working in a GMP environment (preferred), or , GLP, GDP, GCP
3. A working knowledge and practical experience with document / Quality Management Systems, and Electronic Document Management Systems
Key Words: QA | Quality Assurance | QMS | Quality Management Systems | Clinical | GMP | GxP | Biotechnology | QDM | Quality Document Management Systems | Electronic Document Management Systems | Drug Discovery | CAPA | Deviations |
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