Description
New opportunity for an experienced QA Specialist to work for a Global Biotech organization at their site in Ireland.The QA New Product Introduction Specialist (NPI) supports the introduction and execution of New Products in the site facility. The QA Specialist will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product manufacture. day to day QA activities.
Principal Accountabilities:
-Support the introduction of new products onto site in relation to Quality oversight, covering the end to end strategy.
-Participate as functional expert in the cross functional team that manages introduction of Vaccine and Biological products at the site.
-Coordinate and facilitate the Quality Sub Team meetings with internal and external points of contact. (Quality Assurance/ Quality Control and Regulatory)
-Facilitate batch release strategy between supply, manufacturing and packaging sites.
-Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
-Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
-Support the development and approval of product specific automation recipes and associated electronic batch records.
QA Support to Process:
-Participate in site process reviews as the Quality Assurance representative. Ensure that quality issues are identified, addressed and resolved before activities commences.
-Carry out the QA review and approval of postproduction process batch for validated steps prior to release of material by Quality. Provide positive feedback on re-occurring issues thus ensuring continuous improvement to the system. Carry out QA review and approval of the postproduction cleaning records for of validation steps prior to release of material by Quality.
-Provide support to deviation investigations and process performance monitoring on a daily basis.
-Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed. Identification of repeat atypicals or trends during the batch manufacturing process.
-Attend cleaning meeting, review any cleaning investigations and ensure corrective actions are closed out. Review technical assessment and approve cleaning protocols.
Qualifications, Skills & Experience
-The successful applicant will possess the following knowledge, skills, qualifications and experience.
-Bachelor`s Degree in science, engineering or related field
-5yrs+ relevant experience in QA within the pharmaceutical industry
-Solid investigation, root cause analysis and problem solving skills.
-Strong organizational, time management and communication skills.
-Ability to handle multiple tasks simultaneously.
-Proficient with standard office software programs.
-Developed organizational, time management and communication skills.