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Base pay range
Direct message the job poster from Cpl Life Sciences
Principal Consultant – Quality/Scientific
I am looking for a Quality engineer to join a Biotechnology Research organisation based in Cambridge who will help support the production scale-up and expansion to international markets.
The ideal person will be able to ensure products are compliant to local regulations and will work with the governing bodies to meet product approval.
Working with the engineering department to maintain design control and take ownership of engineering change request process to ensure that the technical file is up to date and ready for auditing.
Responsibilities
* Implement and monitor quality control systems to ensure product quality meets the US market's specifications.
* Perform quality audits and manage internal audits to assess adherence to US regulatory standards and best practices.
* Lead corrective and preventive actions (CAPA) for non-conformances.
* Obtain and maintain product compliance across UK, US, and Europe.
* Conduct Gap analyses of current processes.
* Implement a companywide Quality Management System.
* Prepare and maintain documentation, i.e., Technical file, Batch records.
About you
* 4+ years in quality engineer role in appropriate industry.
* Relevant degree to at least BSc.
* Understanding of UK, US, and EU compliance.
* Good technical knowledge of quality management.
* Been audited for ISO9001.
If interested, please apply or send your CV/Cover letter to jamie.keith@cpl.com
Seniority level
Not Applicable
Employment type
Full-time
Job function
Quality Assurance
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