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Document Controller

Hertfordshire   •  Permanent, Full time


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.

Responsibilities:
? 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.

INDLSP


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Sarah Farrow
  • Phone: 0191 384 8906
  • Reference: 51578
  • Updated: 8th September 2021
  • Expires: 6th October 2021

CK Group

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