QA Specialist - NPI
Our client in North Dublin are looking for a QA NPI Specialist on an initial 11 month contract. The successful candidate will have 3+ years GMP ezperience. The role ensures that the New Product Introduction objectives are effectively achieved, consistent to ensure compliance.
Responsibilities:
* 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.
Required:
* Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.
* 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
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at or send your CV to -