Responsible for providing the company with tech and quality resources to run the quality deliverables on projects, coordinating necessary activities for securing the closure of internal/external quality issues and ensuring an effective quality system.
- Bachelor’s degree in a Scientific/Engineering related discipline.
- Strong experience in a Quality Engineering/Quality Assurance role for Biologics, medical device or pharmaceutical manufacturing.
- Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Cert an advantage)
- Knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO)
- Understanding of principles of Validation and New Product Introduction and be familiar with Computerised System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation.
- Previous experience in change control, non-conformance, corrective and preventative actions, and validation practices
- Ability to operate across functional boundaries, both internal and external.
- Flexibility in regard to domestic & international travel is a prerequisite
If interested, please apply with your CV and considering the requirements listed above are met with your experience, you will be contacted with further details.