Excellent opportunity for aQA Compliance Specialist for New Product Introduction to join a Biopharma in Sligo. This is a 12 month contract reporting to the NPI Compliance Manager to support new products being introduced to the Sligo site.
Overview of your responsibilities:
Ensure new products are transferred and manufactured in compliance with applicable regulatory requirements and quality standards.
Support the effective integration of new products into the NPI Quality System.
Coordinate product transfers from development through commercialization, addressing quality risks and implementing mitigation strategies with cross-functional teams.
Support vendor qualification and approval, including the management of technical agreements.
Review and approve analytical method transfers and validation activities related to NPI.
Collaborate with cross-functional stakeholders to identify quality risks, ensure compliance, and provide quality guidance.
Coordinate site reviews of material specifications, including in-process materials, BDS, drug products, raw materials, and excipients.
Knowledge, Skills and Experience Required for the Role:
Third-level qualification in Science, Quality, or a related discipline.
Minimum 3 years’ experience in a quality role supporting new product introductions.
Strong knowledge of regulatory and quality requirements.
Experience in regulatory compliance, quality systems, and NPI activities.
Desirable: 2+ years’ experience in an aseptic manufacturing environment, preferably within Quality.
For a confidential discussion and more information on the role contactCourtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
