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Quality Assurance Specialist

2 weeks ago


Bengaluru, Karnataka, India Syngene International Full time

About Syngene International

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 With a combination of dedicated research facilities for Amgen Baxter Bristol-Myers Squibb and Herbalife as well as 1.9 Mn sq ft of specialist discovery development and manufacturing facilities Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA

Job Purpose
  • Perform QC checks of draft CRF and other study related documents
  • Monitor the pre-check-in check-in pre-dose dosing post-dose study activities as per protocol SOP IOPs and regulatory guidelines
  • Perform Periodic checks for essential documents filed in TMF or study related files at different stages such as before study activity starts during the study and after the completion of the study
  • QC check for source documents transcribed data with CRF entries and other study related documentation

As a Quality Assurance Specialist you will be responsible for ensuring the quality and integrity of clinical trials performed by Syngene International

Responsibilities include:

  • Reviewing and approving CRFs and other study-related documents
  • Maintaining accurate records of study progress and identifying areas for improvement
  • Collaborating with cross-functional teams to resolve issues and ensure compliance with regulations and standards
  • Developing and implementing quality control procedures to ensure high-quality results

This role requires a strong attention to detail excellent organizational skills and the ability to work effectively in a fast-paced environment