Executive/Sr.Manager- Clinical Quality Assurance

Position : Executive/Sr.manager- Clinical Quality Assurance 

Location - Gujarat



Key Responsibilities:

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  Create, review, and implement QA SOPs, GSOPs, and global documents.

  
  


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  Collaborate with R&D stakeholders to develop operational SOPs.

  
  


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  Conduct audits of BA/BE studies (bioanalytical inprocess and retrospective).

  
  


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  Perform system, facility, and process audits.

  
  


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  Audit and qualify/requalify CROs, CSPs, and material suppliers.

  
  


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  Review study documents (protocols, method validation, raw data, reports) for compliance with guidelines and GDP.

  
  


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  Review PBPK/PBBM model reports.

  
  


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  Review SOPs, GSOPs, ATPs, and instrument qualification (IQ/OQ/PQ/DQ).

  
  


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  Revi...