Quality Engineer

Profession QA & Regulatory
Location UK, East Anglia
Salary Up to 45,000 DOE

Description

Quality Engineer

Location: Cambridge

Contract: Full-time and permanent

Sector: Biotechnology

Salary: Competitive and Dependent on experience

 

Our client is an innovative biotechnology company based outside of the centre of Cambridge. They have built a platform to synthesis DNA which provides exciting possibilities for ensuring cheaper, faster and more accurate DNA / gene constructs than traditional plasmid-based methods. In a key phase of their growth, our client is looking to build a robust and driven Quality team to implement a new QMS (Quality Management System) which will be compliant with various ISO and GMP standards. They are looking for Quality Assurance / Engineer professionals who have at least 1 year of experience within a GMP setting to join them on a full-time and permanent basis.

 

The Opportunity

This is an opportunity for Quality Assurance / QA / Quality Engineer professionals who have at least one year of experience within a GMP and pharmaceutical (or biotechnology) setting. This role will involve working within a newly formed Quality team to design and implement a new Quality Management System (QMS). You will be involved in:

 

  • Writing quality system SOPs as well as reviewing, rewriting and validating the documentation.
  • Writing technical SOPs relating to DNA synthesis.
  • Assisting with internal quality audits
  • Support the training of other staff on GMP policies
  • Developing new policies and documents to support the growth of the QMS.
  • Investigating deviations, implementing CAPAs and change control.
  • Working on continuous improvement projects.

 

 

 

 

 

 

 

Skills and Experience Needed

The ideal candidate will have the following:

 

  • BSc / MSc / PhD in a biological / biotechnology discipline (essential)
  • 1 year of previous QA / Quality Assurance / Quality Engineer experience within a GMP and pharmaceutical or biotech environment (essential)
  • Previous GMP quality experience (essential)
  • Experience in maintaining and updating a Quality Management System (QMS) and relevant documents including deviation investigation, CAPAs, change control etc (essential)
  • Good communication skills (essential)
  • Strong understanding of ISO 9001, ISO 13485 (desired)
  • Understanding of DNA synthesis (desired)

 

 

 

 

 

 

 

The Package

As an up-and-coming Cambridge Biotech, our client is able to offer a competitive salary, progression options and benefits package including private pension.

 

To Apply

If you would like to apply to this opportunity, please send a copy of your CV to Charlie Cox at charlie.cox@taylorollinson.co.uk – alternatively, please call Charlie on 07903 204577.

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