Quality Specialist III
1 month ago
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.How you’ll spend your day
Ensure on time dispatch related activity like verification of any deviation/OOS/LIR and other related QMS elements in the batch or 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 corrective or preventive action. Involving in investigation, Review, and ensuring on time closure of the investigation with resolution including corrective and preventive actions along with effectiveness determination. Responsible for assuring / coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements.Your experience and qualifications
Required B Sc/ M Sc qualified candidates 3 to 4 years relevant experience Hands on experience in batch disposition, Batch card review and Batch Release Basic Knowledge about Deviation / OOS Investigation Audit experience of USFDA / EDQM / EMA / TGA / PMDA. At least involved in any of the foreign regulatory Inspection Experience in ERP, TrackWise & LIMS systemTeva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.-
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