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Quality Analyst I

Date: Jun 8, 2022

Location: Bangalore, IN, 560052

Company: Teva Pharmaceuticals

Company Info

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. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

•    To ensure compliance to good clinical practices, good data management practices, standard operating procedures, protocols, regulatory requirements and applicable principles of good laboratory practices in clinical development, Investigators sites and clinical data base 
•    Conducting site audit (approx.: 40% travel), facility and quality system audits 
•    Check for compliance of study related activities to good clinical practice, concerned standard operating procedures and protocol.
•    Review of protocol, Inform Consent Form and Case Report Form for regulatory compliance
•    Review of clinical study data base design and medical coding.
•    Review of electronic case report form specification, edit check specification, UAT plan & report and to perform user acceptance testing.
•    To perform and ensure corporate /policy /standard gap assessment.
•    To ensure and perform Quality management system activities.
•    To ensure study data’s and reports are verified and reviewed.
•    To ensure compliance with respect to the calibration of various equipment’s and software as per standard operating procedure.
•    To provide support in performing investigations and / or preparation and review of investigations report.
•    To prepare and issue of annexures and forms to the clinical development.
•    Monitoring archival and retrieval of the trial related documents.
•    Review of documents and ensure compliance with respect to the calibration of clinical trial instruments and software as per standard operating procedure.
•    Review the validated clinical trial data to ensure consistency, integrity and accuracy based on project specific requirement.
•    Review of data lock process, back up of data and archival.
•    Review of clinical development documents generated during study conduct
•    To perform trend analysis and formal review of corrective action and preventive action for clinical monitoring reports and deviations.
•    Preparation & review of standard operating procedures related to the Clinical development.

Qualifications

•    2-5 years of experience 
•    M Pharma & B Pharma
 

Function

Quality

Sub Function

R&D Quality

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Teva’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.