QA NPI Specialist

7 days ago

Dublin, Ireland Claran Consultants Ltd Full time

Role Description An exciting opportunity has arisen for a Quality Assurance Operations NPI Specialist at Biotech Swords, Co. Dublin. The role ensures that the New Product Introduction objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers, as well as meeting Health Agency regulations and all other applicable governing regulations. Role Functions (Functions include, but are not limited to, the following) With energy, knowledge & innovation, the QA NPI Specialist will: 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. General A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. Strong collaboration and cross-functional leadership skills. Strong verbal and written communication skills, project management skills. Experience, Knowledge & Skills Technical 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 Qualifications & Education Education Bachelors 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. Skills: SAP KNEAT Veeva eVal cGMP IOQ PQ

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