Quality Analyst I

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

• Audit each 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.
• Review the SOPs, forms, formats and log books of all the department(s) and give comments on the same.
• To control and issue the documents i.e. SOPs, forms, formats, log books, study specific protocols, validation protocols, qualification protocols of all departments of BEC site as per SOP.
• To review the change control and deviations as and when assigned.
• Prepare audit report to adhere with the guidelines, written procedures and regulatory inspections and ensure compliance from user department to audit reports.
• Conduct in-process study audit in order to ensure the compliance to GCP/GLP, Protocols, SOPs and applicable regulatory requirements.
• Audit of generated raw data and respective validation report, addendum, bioanalytical report generated from method validation, partial method validation, subject sample analysis of clinical study.
• To share QA audited concentration data to Biostatistician.
• To audit of PK and statistical output of clinical study as per the requirement.
• To audit Biosummary tables (OGD), eCTD compilation of clinical studies.
• Review overall study through audit of ongoing studies, reports and documentation.
• To co-ordinate with user department and medical writer for finalization of bioanalytical reports and clinical study reports.
• Review of audit trail on LC-MS/MS instrument as per SOP.

Qualifications

• 0-2 years’ Experience
• Post Graduate i.e. M.Sc / M Pharma

Function

Sub Function

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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.