Excellent opportunity for a QA Validation Engineer to join a global Biologics Leader in Ireland. The ideal person will have a strong pharma / biopharma background with experience in commissioning and qualification of manufacturing process equipment, analytical and benchtop systems, facilities, utilities and GxP systems.
Overview of your responsibilities (full job description available on request):
- The QA Validation Engineer will provide technical support to QA Engineers and Computerised System Quality Specialists
- The QA Validation Engineer will support team schedule management to ensure project needs are met
- Quality review and approval of qualification/validation documentation and associated data in the following areas:
- facilities, utilities, equipment, computerised systems, cleaning, process, storage areas, controlled temperature units (CTUs) and shipping data
- Ensure compliance with cGMP, industry standards and regulatory requirements.
- Quality review and approval of Standard Operating Procedures (SOPs).
- Preparation of SOPs relating to QA Validation Activities
Knowledge, Skills and Experience Required for the Role:
- A third level degree in a scientific/technical discipline (e.g. biochemistry, chemistry, engineering,) ideal
- Demonstrated experience in commissioning and qualification of manufacturing process equipment, analytical and benchtop systems, facilities, utilities and GxP systems.
- Demonstrated knowledge / experience of cleaning validation, product process validation and shipping validation either as CQV / CSV engineer or as quality reviewer / approver.
- Capability to manage your own schedule, representing dept a key meetings, decision making and problem solving.
- Previous experience in a quality engineering / QA role with robust understanding of GxP regulations would be ideal
- Experience in change control and deviation management would be ideal.
For a confidential discussion and more information on the role contact Courtney Russell
+353 (0) 71 9108062