This organisation is a an award-winning global leader in biopharmaceuticals, with over half a million of biopharmaceutical product expected to be delivered within the next 2 years for over 150 clinical trialas being conducted. They own one of the world's leading greenfield manufacturing sites and are expected to triple their revenue within the next 5 years. Currently, they are looking for a QA Engineer to join their expanding team.
Essential Duties and Responsibilities
- Quality review and approval of qualification/validation documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
- Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations.
- Participate in event/deviation investigation and change evaluation during qualification, to ensure the systems and equipment meet quality and compliance requirements prior to release.
- Responsible for ensuring that all manufacturing processes, QC and Enterprise systems perform and operate as per their design.
- Strong experience in a Quality Engineering/Quality Assurance role for Biologics, medical device or pharmaceutical manufacturing.
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices
- Ability to operate across functional boundaries, both internal and external
To learn more information and have a confidential conversation, call Rachel Duggan on 089 493 7334 or email