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 Review of all documentation i e batch records test results deviation LIR OOS CAPA validation COA Change Controls etc except analytical data related to batch release prior to disposition release or rejection of batch Review of executed document like batch record etc and also to ensure on time compliance of errors deviations identified if any Review of step-by-step performance and compliance to batch manufacturing and packaging record requirements and resolution of any errors deviations identified Monitoring and follow-up of corrective and preventive actions review approval and on time closure of the CAPA in order to resolve an event Review Process documentation i e Protocol report of reviewing effectiveness to determine the effectiveness of a corrective or preventive action Involving in investigation and ensuring on time closure of the investigation and event with resolution including corrective and preventive actions along with effectiveness determination Initiating NTM to Senior Quality Unit Management Operations and other applicable functions for the purpose of expedited communication of critical quality compliance related issues Ensuring Quality interface with internal and external customers when dealing with activities such as issue resolution product information or for movement of materials products or process from site to site Developing Process for observing reviewing and auditing operations activities in order to facilitate batch review and to assure compliance Also ensure self availability on shop floor as per requirement i e support to investigation etc Responsible for assuring coordinating for timely shipment delivery and or receipt to assure compliance with regulatory requirements In addition responsible to assure appropriate shipping instructions coordinate approve route validation and investigation of temperature excursions as required for materials components drug substance and drug product Responsible for oversight and review of R D product development product tech transfer at the site and batch manufacture in GMP areas including resolution of deviations Provide and ensuring support to Regulatory Affairs for Market Authorization MA application and maintenance Responsible for Collection compilation analysis and review of all data i e manufacturing packaging testing sourcing deviations stability and changes etc and information supporting to validation status of a product s Responsible for Review of all documentation associated with the validation of the procedure s used to clean the equipment train for a product s manufacturing and packaging process and cleaning verifications This includes cleaning to remove active ingredients and cleaning agents Responsible for Review of all documentation including protocols and reports associated with the validation of a product s manufacturing and packaging process if required and continuous process verification CPV Assessment of stability requirements based on the type of validation Responsible for Performing reporting of observations and verification of compliance reports of internal audit Qualifications The ideal candidate will have Education B Sc M Sc in Chemistryor B Tech BE Chemical Engineering Experience Minimum 7 to 10 years of industrial experience 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