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Study Director - Preclinical Studies - Ambernath Thane

Study Director - Preclinical Studies - Ambernath Thane

Bharat Serums and Vaccines

7 - 10 years

5 - 10 Lacs

Thane Ambernath

Posted:11 hours ago| Platform:

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Skills Required

GLP training Gmp Compliance GMP

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities 1. Take responsibilities as Study Director for conduct of studies as per GLP principles/ GMP guidelines. 2. Prepare/revise SOPs, formats, logbooks, and ensure test facility implementation 3. Draft study plans, record raw data, study reports, and maintain forms B/D and MSS updates 4. Handle requisition of chemicals, reagents, study related materials. 5. Oversee dosing, observations, necropsy, organ collection, weighing or any other study related activities. 6. Analyze study data with computerized tools ensuring their validation status. 7. Ensure qualification/calibration/AMCs of lab instruments. 8. Organize and complete internal and external SOP/regulatory trainings and implement the procedures in test facility. 9. Oversee preclinical toxicity and PK/PD studies under GLP/GMP guidance

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Bharat Serums and Vaccines

www.bharatserum.com

Biopharmaceuticals

Mumbai

1001-5000 Employees

11 Jobs

Key People

Dr. B. S. A. R. Prasad

Managing Director
Sanjay Tiwari

Chief Financial Officer
Niranjan P. Shetty

Chief Operating Officer

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Study Director - Preclinical Studies - Ambernath Thane