Job Reference: J5631705
Updated On: 14/06/2019
Status: Now Interviewing
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Role OverviewWe are currently looking for a QA Documentation Controller to join a leading biopharmaceutical company based in the Hertfordshire area. As the QA Documentation Controller, you will be responsible for managing the review, approval and archiving of company compliance related documentation.
Key Duties and ResponsibilitiesYour duties as the QA Documentation Controller will be varied. However, the key duties and responsibilities are as follows:
1. You will be responsible for facilitating the effective working of the Quality Management System (QMS).
2. As the QA Documentation Controller, your responsibilities will include the review, approval and archiving of company compliance related documentation to GMP regulatory standards.
3. You will manage the SOP system; author, review and approve Change Control and Deviation Systems, as well as coordinating the product complaints process to facilitate timely close out.
4. As the QA Documentation Controller, you will liaise with the rest of the Quality Assurance team and appropriate Document Owners, and work to reduce risks and improve overall GxP Compliance.
Role RequirementsTo be successful in your application to this exciting opportunity as the QA Documentation Controller, we are looking to identify the following on your profile and history:
1. Relevant degree in a Scientific Discipline
2. Proven industry experience working within a Quality Management System in the Pharmaceutical industry.
3. A working knowledge and practical experience with Document Control, updating SOPs, and actively advising on requirements to close CAPA, Deviations, Audit Observations and Change Controls.
Key Words: Quality Assurance / QA / Documentation / Document Control / SOP / Quality Management System / QMS / eQMS / CAPA / Change Control / Deviation / Pharmaceutical / Compliance / GMP / GxP / Regulations
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