Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.
Post : Quality Analyst III
Job Purpose is To manage the TPO Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirements
• Batch record review and disposition in global system like SAP etc.
• Responsible to follow the Quality Management System of TPO organization, which is relevant to the job function
• Provide impact assessment and risk assessment for impacted CMOs, to the Regional NTM Coordinator for the GNTMs issued, after coordinating with all CMOs
Batch record Review & Release
• Generation of the Trackwise reports for deviations and change controls required for batch release. Review and ensure that there are no open deviations and change controls impacting the release of the batches.
• Review of the temperature reports down loaded from temperature recorders.
• If unsatisfactory result / temperature excursion forward to the investigation team for logging the deviation in the Trackwise and ensure completion before release.
Change Controls : Life cycle management of change control in Global Trackwise system
• Initiate change controls related to the batch manufacturing and packing records specifications and analytical method of analysis stability protocols that are received from the CMOs
• Evaluate the change controls for adequacy and perform line by line review of the documents QC SME for change controls that need analytical evaluation.
• Review the method validation/verifications and method transfer reports associated with the change
• Review process validation/qualification and other associated supporting documents required with the change
Candidate Profile :
• B.Pharm, / M.Pharm / M.Sc. (Science), B.S. Sciences.
• Minimum 6 – 8 years of experience in pharmaceutical industry ,Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing supply chain environment . Knowledge on Compliance Standards and Regulation as applicable to the market , Experience of handling Operational Quality QA/QC exposure and External / Contract manufacturing site
• Knowledge and working experience with USFDA / EU and other competent authority approved sites
Experience : 6 – 8 years
Qualification : B.Pharm, / M.Pharm / M.Sc
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality
End Date : 25th September, 2020