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Group Leader Quality Assurance

8 - 12 years

0 Lacs

navi mumbai maharashtra

Posted:2 weeks ago| Platform: Shine logo

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Skills Required

quality management system auditing gcp glp statistical analysis change control deviation management risk assessment capa sops clinical activities pharmacokinetic analysis sdtm data review regulatory inspections

Work Mode

On-site

Job Type

Full Time

Job Description

As a Clinical Quality Assurance professional at WPPL, you will play a crucial role in ensuring the establishment, implementation, and maintenance of processes required for the Quality Management System. Your responsibilities will include reporting on the performance of the quality system, planning and executing clinical activities, and conducting various audits across departments. You will be responsible for reviewing equipment installation, qualification, calibration, and preventive maintenance in the clinical department, ensuring compliance with relevant SOPs and guidelines. Additionally, you will review clinical data, pharmacokinetic analysis, statistical output, and statistical analysis reports to ensure accuracy and adherence to protocols. As part of your role, you will conduct external vendor audits, review raw data of clinical projects, and perform internal study audits to assess compliance with GCP/GLP, protocols, SOPs, and regulatory requirements. You will also review and evaluate change controls, deviations, CAPAs, and conduct facility assessments at clinical and pathology laboratories. Collaborating with the Head-QA, you will support regulatory inspections and audits, review responses to queries, and ensure timely implementation of CAPA actions based on investigative results. Additionally, you will update policies, quality manuals, SOPs, and work documents, providing valuable insights and comments for their approval. Your role will involve monitoring studies at external CROs, conducting meetings with clinical and pathology laboratory departments to update on quality systems, and taking on other responsibilities as assigned. With your M.Sc, M.Pharm, or Ph.D. qualification and 8-10 years of experience in Clinical Quality Assurance for BA/BE studies, you will report to the Associate Director Quality Function. Join us at WPPL and be part of a mission-driven team dedicated to making a positive impact on global healthcare by ensuring quality and compliance in clinical activities and processes.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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