Were currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Cork.
This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Key Responsibilities: Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.
Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems.
Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
Execute/Participate in change controls and other compliance related tasks e.g.
non-conformances.
Support regulatory audits Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
Support, lead or guide others in CQV projects.
Education & Experience Requirements: Degree in a Science or Engineering discipline.
Experience in a GMP environment essential.
Minimum 5 years experience in a similar role.
Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels If interested in this posting please feel free to contact Sen Mc Carthy on or for further information.