Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
Post : Syngene International Limited (Bengaluru) for a Clinical Trials - QA
Key Responsibilities
• To perform the role as Clinical Trials - QA auditor to verify compliance with respect to ICH-GCP, applicable regulatory requirements and Study Protocol for Clinical site, Pharmacy, Biometrics, clinical data management and medical writing activities for patient based (Phase I, II, III and IV) studies.
• GCP clinical Trial QA auditor with 6-9 years of experience in performing Clinical trials investigational sites GCP QA audits across India and other international destinations.
• Collate data for clinical quality metrics and report.
• Perform system and study audits with respect to Pharmacy, Biometrics, clinical data management and medical writing functions.
• Perform vendor audits based upon quality risk assessment.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Attend training on environment, health, and safety (EHS) measures imparted company.
Experience : 5-10 years
Interested can share resume to Jaideep.K@syngeneintl.com
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