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GMP Document Controller

King's College London - Centre for Cell & Gene Therapy (CCGT), Medical and Molecular Genetics

Location: London
Salary: £32,676 to £37,297 per annum, including London Weighting Allowance
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 7th September 2021
Closes: 3rd October 2021
Job Ref: 031288
 

Job description

Role purpose

The Centre for Cell and Gene Therapy (CCGT) manufactures Advanced Therapy Medicinal Products (ATMPs) for a wide variety of novel gene and cell therapies for the treatment of cancers to rare diseases. This is an opportunity to work within one of the largest academic GMP facilities in Europe focusing on the delivery of gene therapy products for early phase clinical trials.

The post holder will work as GMP Document Controller interacting with the production and quality teams and be involved in supporting the production and testing of Investigational Medicinal Products (IMPs) and Specials. The post holder will be mainly responsible for operational document control of the Pharmaceutical Quality System ensuring GMP compliance. It will be the responsisbility of the Document Controller to ensure all documentation is updated and uploaded unto a password protected and secured central Document Control system on QPULSE in a timely manner, completing all tasks related to revision, review, approval and issue of controlled documents within the next date of review. The Document Controller will also need to provide a range of administrative support, including secretarial support to the management team at the Guy’s campus.

We are looking for a highly-motivated individual who is interested to take up the challenging role as Document Controller working in a GMP manufacturing facility. Biological or pharmaceutical background and previous GMP experience is highly desirable, but not essential. Ideal candidate should have excellent organisational skills and good attention to detail. Experience in MS Office computer skills would be essential to create, access and submit reports for review and approval.

Role profile

The Document Controller is responsible for providing controlled documentation to production and quality teams to ensure compliance with GMP, including:

  • Organisation of master copies of Standard Operating Procedures (SOPs) and Quality Management Procedures including previous issues of documents, recalled controlled copies, procedure issue notes and completed procedure reviews for monthly documentation review conducted by in-house quality audits.
  • Co-ordinate the review of documents requiring regular review and/or update, providing quarterly ‘document status report’ to Head of Production and Quality.
  • As a trained GMP Document Controller, provide written summary reports related to document control for annual internal audits, MHRA inspection, as required.
  • Update training record spreadsheet to monitor and assign training of SOPs and QMPs, and email group to notify training due dates for GMP compliance.
  • Update equipment calibration spreadsheet and contact suppliers to arrange and schedule calibration/maintenance visits
  • Record incoming goods and obtain and file certificates of analysis for GMP compliance.
  • Issue of purchase requisitions and resolution of invoice queries.
  • Type, collate and circulate reports, minutes, agendas and relevant administration support papers.
  • IT related activities such as webpage development and update.

This post will be offered on a fixed-term contract for 30 months in the first instance

This is a full-time post - 100% full time equivalent

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