Excellent opportunity to join a global manufacturing company for a 12 month contract based in Loughborough.
As an experienced Quality Engineer you will maintain the Quality Management System; driving and managing long term improvement and lean activities to ensure customer and company needs are met. Provide the technical compliance support to the whole site, ensuring appropriate internal communications and developing compliance understanding across site. Provide compliance support for introduction of new product introduction.
I am interested to talk with candidates who can fulfil most of the background and experience below:
*Degree in Chemistry or Pharmacy or related subject.
*Familiarity with Quality System requirements, the 'Orange Guide', equivalent FDA regulations and ISO EN 9000 and ISO EN 13485 requirements.
*Knowledge of GMP/GCP Regulatory requirements.
*Minimum 3 years' experience in GLP/GMP within a contract manufacturing environment of the Pharmaceutical/Medical Device industry.
*Experience of Design of Experiments, FMEA, and other process investigational techniques.
*Demonstrated competency in auditing for internal audits preferred.
*Demonstrated competency in customer negotiations and technical discussions is preferred.
*Previous experience of batch record review (e.g. Document Assurance/Quality Control release) an advantage
Apply now for full details.
