The Company

My client, a global leading Biopharmaceutical organisation are expanding their Plant Quality Assurance (PQA) team and are looking for a QA Senior Associate to join their team and support this ongoing expansion. This Dublin site houses the large-scale production of vials and syringes which contain treatment medication for oncology, rheumatology and other autoimmune illnesses. Their product portfolio currently sits at 10 and is ever growing in response to global health requirements.

The Role

The Quality Assurance (QA) Senior Associate will typically report to a Senior QA Manager and is a core member of the site Quality Assurance team, and will serve as Quality point of contact for Plant Quality Assurance. Some key responsibilities:

• Observe and provide real-time quality oversight and support for inspection and packaging unit operations.
• Participate in customer complaint investigations.
• Perform packaging check audits.
• Provide quality support for triage and investigation of all classes of deviation events.
• Review and approval of deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
• Review/approve production batch records and associated documentation in preparation for Qualified Person disposition activities.

The Person

The successful candidate will have:

• Bachelors Degree in an Engineering or Science related discipline preferred.
• Relevant experience (4 years +) working in the pharmaceutical or biotechnology.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

To discover more about this opportunity, apply now or contact Helena Boyle on (01) 6321870/0873360953 for a confidential discussion.