CK Group are recruiting for a Document Controller on behalf of a clinical-stage immuno-oncology therapeutics developer, to be based at their growing site in Stevenage on a permanent basis.
The organisation recently embarked on establishing a new cGMP manufacturing operation, to provide manufacturing capacity for Phase 1 and Phase 2 operations, for their novel T cell platform.
The Document Controller will report to the QA Director and will support primarily the QA department and as applicable all other site functions with regards to QA/GMP administrative and document management tasks. This position offers an exciting opportunity to join the Stevenage team at an early stage, to deliver life saving therapies to cancer patients across a broad class of indications.
? Liaising with Production, Quality Control, Quality Assurance, Regulatory Affairs and Supply Chain personnel to manage GMP controlled document issuance, distribution, reconciliation, archival and destruction activities.
? Supporting QA team members with administrative tasks such as filing, printing copying where required.
? Providing document control and role associated training to site personnel.
? Maintaining and supporting processes for quality metrics reporting.
? Maintenance of reliable document storage and archiving systems, both paper-based and electronic, to maintain the integrity of the records.
? Providing regular reports as required for quality meetings, executive meetings.
To be considered for the position you should have the following skills and experience:
? Experience of QA document control or a similar administrative role in a GMP manufacturing environment (ideally steriles or biologics).
? Proficiency in the use of computer software, including Electronic Documentation Management Systems (EDMS)/Quality Management systems (eQMS).
Entitlement to work in the UK is essential. Please quote reference 51578.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Sarah Farrow
- Phone: 0191 384 8906
- Reference: 51578
Website: CK Group
- Updated: 8th September 2021
- Expires: 6th October 2021