Contract: Full-time and permanent
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.
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)
As an up-and-coming Cambridge Biotech, our client is able to offer a competitive salary, progression options and benefits package including private pension.
If you would like to apply to this opportunity, please send a copy of your CV to Charlie Cox at email@example.com – alternatively, please call Charlie on 07903 204577.