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.
Post : Quality Senior Specialist
• Review of protocol against applicable regulatory guidelines.
• Review and check of all bioanalytical documents, method validation, bioanalytical report, statistical reports and clinical study report.
• Review of relevant standard operating procedures to check compliance with regulatory guidelines and suggest appropriate modifications if any.
• Preparation of standard operating procedures related to Bioanalytical Quality assurance department.
• Retrieval of documents from archives as and when required.
• Verification of system compliance of the system with respect to the standard operating procedures and other applicable regulatory requirements and to the response to the queries.
• Aware on various regulatory guideline such FDA,EMA,ANVISA,GCP&GLP
• Must be a Masters graduate in Science/M. Pharm
• Knowledgeable about QA processes in CRO environment
Qualification : M.Sc, M.Pharm
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 20th April, 2019
See All Other Jobs in our Database