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Teva Pharmaceuticals
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Quality Analyst I

Quality Analyst I

Teva Pharmaceuticals

3 - 7 years

0 Lacs

navi mumbai maharashtra

Posted:3 days ago| Platform: Shine logo

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Skills Required

quality assurance audit gcp glp sops bioanalytical clinical study biostatistics regulatory inspections lcmsms vendor audits calibration records

Work Mode

On-site

Job Type

Full Time

Job Description

As a Quality Analyst I at Teva Pharmaceuticals, you will be responsible for auditing each BA/BE study to ensure that facilities, personnel, equipment, instruments, protocols, methods, practice, records, and controls comply with relevant GCP/GLP guidelines, protocols, and SOPs. Your day will involve reviewing SOPs, forms, logbooks of departments, providing feedback, reviewing change control and deviations, and preparing audit reports in accordance with guidelines and regulatory inspections. You will also conduct in-process study audits to ensure compliance with GCP/GLP, protocols, SOPs, and regulatory requirements. Additionally, you will audit raw data, validation reports, bioanalytical reports, PK and statistical outputs, bio-summary tables, eCTD compilations, and collaborate with Biostatisticians and medical writers for finalization of reports. Furthermore, you will review audit trails on LC-MS/MS instruments, conduct area-specific audits, system audits, vendor audits, calibration records, and issue documents such as SOPs, protocols, and logbooks. Your role will involve ensuring compliance and adherence to quality standards in bioanalytical processes. To qualify for this role, you should have a B.Pharm, M.Pharm, or M.Sc degree with 3-6 years of experience in Bioanalytical Quality Assurance for a BA/BE Study. Join us on our mission to make good health more affordable and accessible, impacting millions of lives worldwide. Apply now to be a part of Teva Pharmaceuticals and contribute to our commitment to Equal Employment Opportunity.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Quality Analyst I