Quality Document Controller

2 weeks ago


Newcastle upon Tyne, United Kingdom Iksuda Therapeutics Full time

**Quality Document Controller**

Iksuda Therapeutics is a Biotechnology Company focused on the development of Antibody Drug Conjugates (ADCs) for the treatment of cancer.

An exciting opportunity for a Quality Document Controller to assist in the development and ongoing management of Iksuda's Quality Management System.

**Experience in a similar role essential.**

**Knowledge of GCP, GMP, GLP, GDP preferred. Definitely GMP and basic knowledge of GCP would be an advantage but GDP and GLP not as critical**
- Document Control - generate, manage, update/upload, retrieve and follow-up quality documents, generated both internally and generated by vendors, in the QMS
- Maintain read only access folder of effective SOPs, forms and templates for reference by Iksuda personnel
- Provide working copies of forms and templates as requested for deviations, changes, questionnaires etc.
- Review and verify documents for completeness, format, and compliance with applicable requirements
- Act as gatekeeper for documents being uploaded to the QMS ensuring all details are present and documents are appropriately logged
- Routing new and update quality documents and forms for review and approval through DocuSign; monitor to confirm process complete within specified time frame and store completed documents appropriately
- QMS document administration including password setup, general training, and user inquiries this is not needed at this point as we dont have an eQMS.
- Maintain Training Log (assign and track associated training to SOPs) and training plans based on approved training matrices
- Ensure SOPs are reviewed periodically in line with effective date
- Ensure all SOPs have associated training quizes within a traceable system for training
- Ensure all general access SOPs and forms and related management system documentation are controlled and that only current versions are available for use
- Maintain vendor files within the QMS ensuring follow up on audit responses and renewal of certificates and agreements as part of the vendor management process
- Maintain the restricted access Quality sharepoint folders and ensure documents are logged and filed appropriately.
- Report metrics on status of documents and training on a regular basis
- Assist in follow up with vendors as requested
- Assist with the Quality Management Review information gathering and presentation development
- Assist with internal and external inspections and retrieval of documents as required.

**Qualifications**:

- Experience with document/quality management systems
- Knowledge of Electronic Document Management System(s)
- Proficiency in use of DocuSign, Dropbox, Microsoft Word, PowerPoint and Excel

**Skills**:

- Excellent communication
- Extremely organised
- Great attention to detail
- Ability to prioritise workload

**Experience**:

- Document management systems: 1 year (required)

**Job Types**: Full-time, Permanent

**Salary**: £25,000.00-£28,000.00 per year

Schedule:

- Monday to Friday

Work Location: In person

Application deadline: 11/04/2024
Reference ID: Quality Document Controller



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