Quality Assurance - Pharmacovigilance-Crest

6,00,000 - 8,50,000 P.A
Job Description

• Communicate with Operations and clients to ensure compliance with Project Sops and Regulatory guidelines
• Prepare for regulatory as well as client audit
• Act as Compliance / safety lead for projects
• Prepare & conduct Internal Audits
• Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with Compliance standards and policies, GVP, GDP and regulatory requirements by performing the following
• Establish and manage Annual Quality Plans approved by relevant stake holders
• Corrective and Preventive Actions (CAPA) (including RCA and deviations)- Develop local processes based on global ones to conduct root cause analysis to investigate deviations and develop CAPAs. Demonstrate that the CAPA plans required are effectively implemented, monitored and closed out.
• Auditing Ensure a Local process is in place to support Audit activities as necessary, including Health Authorities Inspections. 
• Assist with self-inspections and ensuing corrective/preventive actions
• Manage quality alerts and regulatory intelligence.
• Manage Local Training activities as necessary. 
• Ensure the maintenance of the QMS through the appropriate impact assessment and QMS Management review processes.

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