Who are we?
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!
Responsible for planning and executing the QA activities for Bioanalytical, Pharmacokinetics and Biostatistics departments.
Report on the performance of the quality system to the Head-QA for review and as a basis for improvement of the system.
Co-ordinate with internal and external parties (Biopharm team) on matters relating to quality system.
Ensure compliance to SOP, GCP/GLP and applicable regulatory guidance\'s.
Monitor the bioanalytical projects to ensure that all the data of the bioanalytical phase is audited before submission of study report to sponsor.
Review of raw data of respective method book, method validation, partial method validation, study as and when required.
Review equipment installation, qualification, calibration and preventive maintenance in Bioanalytical and verify that these activities are conducted as scheduled.
Review of PK data, statistical output of clinical study as per the requirement.
Conduct external vendor qualification audit as and when assigned.
Maintain and track Change Control system at BEC site as per SOP.
Qualifications
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