Description:
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