Orion Group Life Sciences are currently recruiting a QA NPI Specialist on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-month contract with potential to extend.

Role Functions:

• Review and approve change controls, corrective and preventive actions (CAPAs), deviations including investigation protocols, root cause analysis and final investigation reports.
• Review and approve batch records
• Review and approval of Equipment qualification including IOQ and PQ, process validation, development studies, hold time studies etc.
• Provide quality assurance support across functional and cross-functional forums.
• Oversee quality aspects of material and supplier management, including preparation of material qualification packages, supplier audit assessments, and maintenance of the supplier management system.
• Collaborate with stakeholders such as Quality Control (QC), Manufacturing Science & Technology (MS&T), Engineering, and Warehouse to develop, review, and maintain documentation and quality records throughout the product lifecycle (e.g., method validations, facility upgrades, qualification protocols, calibration records).
• Review and approve Good Manufacturing Practice (GMP) documentation and data to ensure accuracy, completeness, and compliance.
• Partner cross-functionally to support timely delivery of project milestones.
• Contribute to the identification, development, and execution of continuous improvement initiatives and action plans in collaboration with cross-functional teams.
• Ensure the highest Quality, Compliance and Safety standards.

Experience/Education

• Strong knowledge of qualification and implementation of Single Use technologies and raw materials and supplier qualifications for use in a GMP environment.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Proven track record in delivering excellence.
• Competency in the use of SAP, KNEAT, eVal and Veeva systems including change control is an advantage.
• Familiarity and participation in risk assessment processes
• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.
• 5 to 8 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.

 

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.