Teva Pharma Mumbai Job For Quality Sr Specialist
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!
Education & Qualification Details
Education
BPharm / MSc
Fresher MPharm QA
Designation : Quality Sr Specialist-R&D Quality
Location: Navi Mumbai, IN, 400706
Job Description
Inspect / audit bioanalytical phase of BA/BE studies (both pre and post study) to assure the management that the facilities, personnel, equipment, instruments, protocols, methods, practice, records and controls are in conformance with the relevant and current GCP/applicable GLP guidelines, protocols and SOPs implemented within the department(s) of WPPL BEC site.
Review / update the SOPs, forms, formats and log books of WPPL BEC prior to their approval and give comments on the same. Perform ‘Document control and issuance’ activities for SOPs, forms, formats, log books, study specific protocols, validation protocols, qualification protocols of all departments of WPPL BEC site.
Conduct in-process study audits, system audits and external contractual audits for compliance with GCP/GLP, Protocols, SOPs and applicable regulatory requirements.Review of generated raw data and respective validation report, addendum, bioanalytical report generated from method validation, partial method validation, subject sample analysis of clinical study.
Review of Winnonlin data, statistical output of clinical study as per the requirement. Review the final eCTD compilation of reports submitted to regulatory.
Prepare audit reports to adhere with the guidelines, written procedures and regulatory inspections.
Ensure CAPA actions based on the results of the investigations are identified and implemented.Conduct in process audit for studies conducted at WPPL, BEC as and when directed. For instance, prior to a regulatory / sponsor / other inspections.
Verify equipment installation, qualification, calibration and preventive maintenance in laboratory is conducted as scheduled.Archiving and maintaining all documents received from various department of WPPL BEC. To carry out other responsibilities as and when assigned by the Head of Department or designee.