Our client, a global biologics corporation specialises in providing end to end solutions for the development and manufacturing of biologics in North Leinster. They are known for their state-of-the-art facilities and expertise in the biopharma industry. They are currently seeking to hire a Senior QA Validation Engineer for a 12 month contract.
- 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.
- Work with all personnel, contractors, and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.
- Good understanding of the principles of qualification and validation of equipment and utilities.
- 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.
- 12 month contract.
- Competitive hourly rate.
- Co Louth location.
To discover more about this opportunity please apply online or contact Olivia Rogers at HRM Search Partners on +353 1 6321802 for a confidential discussion.