My client is a leading global biopharmaceutical organisation who have a large aseptic operations facility, specialising in secondary manufacturing activities - formulation, fill and packaging based in South Dublin. This 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.

Due to ongoing expansion on-site, an opportunity has arisen within the Incoming Quality Assurance (IQA) Department for a QA Senior Associate.

The Role

The Sr. Associate in Quality Assurance will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components. Some of their main responsibilities will include:

• Testing of primary and secondary components for use in the manufacture of aseptic products.
• Sampling of Excipients and Drug Substance under Grade C conditions.
• Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation.
• Participates in customer complaint investigations with suppliers of components.
• Review and approve cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation.

The Person

The successful candidate will have:

• Bachelors degree in Engineering or Science related discipline.
• Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
• Ideally, experience working in aseptic operations, protein formulation, vial and syringe filling.

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