01Overview
What You Will Achieve In this role, you will: Evaluate and review commercial drug batches to ensure compliance with established specifications. Ensuring Zero Defect Technology transfer for new product transfers into site. Quality Support and review of Scale-up, pilot bio batches and exhibit beaches to meet regulatory expectations. Reviews of Process validation protocols and reports to meet regulatory expectations. Review of Optimization Report /Technology Transfer Report, Analytical Data Sheet and Stability Data. Responsible to manage New Product Introduction (NPI) projects. Review and approval of Project validation protocols, QRMs, Cleaning validation protocols and reports, process validation protocols & reports, Filter validation protocols & reports. Review of Analytical Method Transfer and method validation Reports and ensuring the key changes mentioned in the other transfer sites. Continuous improvement of templates for presentations, timelines, trackers, and other tools, Review , approval and ensure the compliance of SOPs related to technology transfer . Review and approval of validation protocols , PRQs and PRs to ensure validation life cycle . Support production related documents review and approvals Approve investigations and change control activities to maintain compliance with configuration management policies. Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards. Here Is What You Need (Minimum Requirements) Qualification : B.Pharm /M. Pharm/M.Sc Experience : 6 to 7 years of experience in sterile injectable technology transfers/ quality Assurance /validations. Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards Strong critical thinking skills Ability to work effectively within own team and interdepartmental teams Good working knowledge of Microsoft Excel and Word Proactive approach to problem-solving Work Location Assignment: On Premise Pfizer es un empleador de igualdad de oportunidades y cumple con toda la legislacin aplicable en materia de igualdad de oportunidades en el empleo en cada jurisdiccin en la que opera. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Quality Assurance and Control Una carrera en Pfizer es como ninguna otra. En nuestra cultura de propiedad individual, creemos en nuestra capacidad para mejorar el futuro de la sanidad y en nuestro potencial para cambiar millones de vidas. Estamos buscando talento nuevo para unirse a nuestra comunidad global, para descubrir nuevas terapias innovadoras que hagan del mundo un lugar con mejor salud. .
