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Teva Pharmaceuticals
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Group Leader Quality Assurance

Group Leader Quality Assurance

Teva Pharmaceuticals

8 - 12 years

0 Lacs

navi mumbai maharashtra

Posted:5 days ago| Platform: Shine logo

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Skills Required

quality management system data analysis sops gcp equipment maintenance change control capa clinical activities audits regulatory inspections glp guidelines riskbased assessment audits

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for ensuring the establishment, implementation, and maintenance of processes needed for the Quality Management System at the company. Reporting on the quality system's performance to the Head-QA for review and improvement will be a key part of your role. Additionally, you will plan and execute clinical activities, conduct audits, review equipment maintenance, data analysis, and support regulatory inspections. Key Responsibilities: - Ensure establishment, implementation, and maintenance of processes for the Quality Management System. - Report on the performance of the quality system to the Head-QA and suggest improvements. - Plan and execute clinical activities, ensuring compliance with relevant SOPs, GCP, and GLP guidelines. - Conduct general and system audits for all departments. - Review equipment installation, qualification, calibration, and maintenance in the clinical department. - Review and analyze data from clinical studies, including statistical outputs and study reports. - Conduct external vendor audits and review raw data of clinical projects. - Perform internal study audits to ensure compliance with GCP/GLP, Protocols, SOPs, and regulatory requirements. - Review Change Control, deviations, and CAPA's, evaluating their impact. - Conduct facility and risk-based assessment audits at clinical and pathology laboratories. - Support regulatory inspections and audits, reviewing responses to queries and implementing CAPA actions. - Update Policies, Quality Manual, Site Master File, SOPs, and work documents periodically. - Conduct monitoring of studies at external CROs and perform other assigned responsibilities. - Conduct meetings with clinical and pathology laboratory departments to update on the quality system. Qualifications Required: - M.Sc, M.Pharm, or Ph.D in relevant field. - 8-10 years of experience in Clinical Quality Assurance for BA/BE Studies.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Group Leader Quality Assurance