We're 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 environment.
If interested in this posting please feel free to contact Seán McCarthy on or for further information.