GMP Document Administrator

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Job Details

Location
Darlington, England
Salary
£21,030 - £25,400 per annum- dependent on experience
Employment
Full-time - Permanent
Team
Quality
Deadline
16 Jun 2023 - 23:45
Reference
CPI-7442-23
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About CPI

CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.

Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.

From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.

Why this role is important for CPI’s work

As the GMP Document Administrator, you will be responsible for establishing and maintaining the document management processes including the issuing and reconciliation of GMP documentation. You will be joining the established, growing Quality team. Reporting to the Quality Manager – Biologics, you will be working in CPI’s National Manufacturing Biologics Centre and supporting the new, state-of-the-art RNA Centre of Excellence, also based at the site in Darlington.

You will perform a variety of tasks in support of Document Control Systems’ and Writing, Reviewing, Version Control, Issuing & Archiving of BMR’s and Logbooks to ensure compliance to the CPI Biologics quality management system to meet GMP requirements.

Key tasks will include (but are not limited to) the below:

  • Document controller activities for all GMP controlled documentation including policies, SOPs and protocols.
  • Control, issue, reconciliation, and archive of GMP manufacturing documentation including batch manufacturing records and logbooks. 
  • Printing, issuing and reconciliation of labels.
  • Supporting the Quality team with any other requirements as required.

The person we are seeking

You will be educated to a minimum of 5 GCSE’s (or equivalent) including Mathematics and English Language.

You will have great attention to detail. 

It would be great if you had:

  • Document management expertise and experience of operating within a quality management system.
  • Use and implementation of paper and electronic Document Management systems.

What does CPI offer you?

At CPI, we offer a wide range of benefits to our employees, this includes:

  • Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
  • Generous pension scheme
  • Life assurance and accident insurance schemes
  • Flexible working
  • Learning and Development Opportunities
  • Free parking

Find out more about our culture and benefits.

Additional information

CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.

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