Quality Senior Specialist

3 weeks ago

Gwalior, India TAPI Full time

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 We re looking for a detail-driven Quality Senior Specialist with a strong foundation in GMP GLP compliance and audit readiness What are your responsibilities Ensure on time dispatch related activity like verification of any deviation OOS LIR other related QMS elements in the batch or in its batch train Ensure review of all documentation i e batch records test results deviation LIR OOS CAPA validation COA Change Controls etc and perform disposition release rejection of batches Ensure review of executed document like batch record analytical data etc and to ensure on time compliance of error deviations identified if any 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 and approval Process documentation i e Protocol report of reviewing effectiveness to determine the effectiveness of a CAPA Involving in investigation Review and ensuring on time closure of the investigation with resolution including CAPAs along with effectiveness determination Responsible for assuring coordinating for timely shipment delivery and or receipt to assure compliance with regulatory requirements Responsible for preparation of Annual quality review periodic quality review Any task assigned by QA manager Skills Good understanding of Pharmaceutical Quality System GMP GLP Qualifications The ideal candidate must have M Sc with 3-5 years of experience 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

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