Quality Analyst

Company Description At TAPI we re not just a company we re a community committed to advancing health from the core As the world s leading supplier of active pharmaceutical ingredients APIs we partner with 80 of the top 50 global pharmaceutical companies With a legacy spanning over 80 years and a portfolio of more than 350 products as well as custom CDMO services we re shaping the future of health worldwide Our strength lies in our people a team of over 4 200 professionals across 13 state-of-the-art facilities in Italy Hungary the Czech Republic Croatia Israel Mexico and India Together we innovate solve problems and deliver excellence Join us and be part of a mission that transforms lives Key Responsibilities Responsible for processing and oversight of changes through the generation justification impact assessment modification review approval and implementation workflow This includes but is not limited to SOPs production records test methods specifications protocols reports equipment processes material suppliers facilities computer systems etc Responsible for processing of documents through the generation modification review and approval workflow This includes but is not limited to SOPs production records test methods protocols reports labeling etc also archival of records Responsible for review approval of all documentation associated with the establishment and configuration of GMP equipment including laboratory equipment This includes any Installation Qualification IQ Operational Qualification OQ and Performance Qualification PQ documents Responsible for tracking trending and reporting of quality metrics for site regional and global review Trending as required by SOP Corp Standards and or regulations Responsible for review approval of all documentation associated with the establishment and configuration of a GMP computerized system This includes all lifecycle documents Responsible for Review of regulatory and quality compliance requirements and global procedures performance of gap assessments and establishment or improvement of SOPs covering all areas of applicability Development and monitoring of corrective action plans where needed Ensuring quality support to regulatory affairs as it relates to updates changes to market authorizations Review of all documentation i e LIR OOS Change Controls etc Ensuring and performing investigation into a product quality complaint with resolution including corrective and preventive actions and closure of the investigation Ensure review approval and on time closure of the laboratory investigation events with resolution including corrective and preventive actions along with effectiveness determination Ensuring quality oversight of maintenance and calibration activities including facilities and equipment and any critical systems such as process water etc Responsible for management of regulatory authority and other external compliance audits e g Customer audits including communication tracking and resolution of observations Management of communications with regulatory agencies including required reporting and resolution of any actions required by the agencies Qualifications The ideal candidate will have Education M Sc in Chemistry or B Tech BE Chemical Engineering or B Pharma Experience Minimum 10 years of experience in a regulated pharmaceutical environment Preferred Industries API Pharma Additional Information Make Your Mark with TAPI Your journey with TAPI is more than a job it s an opportunity to make a lasting impact on global health If you re ready to lead innovate and inspire we re excited to welcome you to our team Together let s shape the future of pharmaceuticals Apply on top of this page and our talent acquisition team will be in touch soon