A leading Biotech Consultancy firm in Carlow is looking for a Quality Assurance professional to provide oversight for new products and materials. You will ensure compliance with regulatory standards while collaborating with cross-functional teams. Ideal candidates have 3-5 years of experience in quality roles within the pharmaceutical sector, robust regulatory knowledge, and strong report writing skills. The position offers a permanent contract and career development opportunities. #J-18808-Ljbffr
Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Carlow State/Province Carlow Country Ireland Job Description About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met. Requirements Role Functions: Provide quality oversight and direction for theintroduction of new products and materials, as well as manage external parties. Provide QA oversight to support Analytical, Warehouse andFacilities Management, including deviations, Root cause analysis, CAPAs andchange controls Participate as a functional expert in thecross-functional team responsible for introducing products and materials Review documentation associated with new product andmaterial introduction, such as Material Packs, QC Test Specifications, BOMs,Supplier Qualification and Oversight. Develop and monitor supplier performance metrics,participate in material review boards and quarterly reviews of key suppliers,and actively engage in cross-functional forums as needed. Maintain the approved supplier management list within thequalified Supplier Management system, ensuring correct setup of suppliers andmaterials used Support deviation and atypical closeout, as well asinitiate and follow up on corrective and preventive actions. Author, review, and approve protocols and reports fortechnology transfer, method qualification, and method validation. Conduct quality reviews and approvals ofengineering/validation/automation/utilities commissioning and qualificationactivities. Serve as the point of contact for quality at both thesite level and with external inputs, coordinating and attending Quality workinggroup meetings. Facilitate compliance direction for the site by adheringto divisional policies, guidelines, and regulatory requirements. Proactivelyevaluate site compliance against emerging trends and initiate major complianceinitiatives for improved status and operational efficiency. Activelyparticipate in Plant/Quality committees and collaborate with other sitefunctional groups. Experience, Knowledge & Skills: A minimum of 3-5 years of experience in a quality role,ideally in a pharmaceutical manufacturing environment. Knowledge of regulatory/code requirements related toIrish, European, and International Codes, Standards, and Practices. Familiarity with cGMP (current Good ManufacturingPractice) and GDP (Good Distribution Practice) is preferred. Strong report, standards, and policy writing skills. Experience with equipment and process validation. Familiarity with sterile filling processes and equipment. Proficiency in Microsoft Office and job-related computerapplications. Experience or familiarity with Lean Six Sigma methodologyis desired. Good collaboration skills and the ability to workeffectively as part of a team to determine priorities. Demonstrated ability to work independently and takeownership of improvement initiatives with a moderate level of guidance. Proven ability to drive the completion of tasks. Strong decision-making capability with a sense ofaccountability and responsibility. Demonstrated problem-solving skills Qualifications & Education: A Bachelor's degree or higher in a related Sciencediscipline is preferred. #J-18808-Ljbffr
