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 Analysts
Experience : 2-4 years experience specific to Bioanalytical Quality Assurance process.
Qualification : M.Pharm / M.Sc
Responsibilities :
• Review of protocol against applicable regulatory guidelines & applicable SOPs.
• Preparation review of relevant standard operating procedures to check compliance with regulatory guidelines & suggest appropriate modifications if any.
• Retrieval and archival of documents as and when required.
• Review and distribution of bioanalytical methods, validation protocols, bioanalytical protocols & standard operating procedures.
• Review of documents and ensure compliance with respect to the validation and calibration of analytical instruments & software as per standard operating procedure & validation master plan.
• To perform scheduled internal audits, vendor audits, external monitoring, remote audits, facility audits, and to ensure if they are completed as per the schedule.
Job Location : Bangalore
Note : Incumbent must be aware of GCP, GLP, FDA, EMA guideline requirement specific to BA/BE study conduct and must have exposure of management of log books and forms.
Note : Please note that Minimum 2 yrs of experience is Mandatory.
This will be a planned Face to face interview hence please share your cv first in poulomi.mitra@teva.co.in with the subject line (6th Jan'23 - Bioanalytical QA Drive).
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