iMED Blr is hiring TL/Specialist For Quality @ Imedglobal Solutions

Job Description

• Develop and maintain policies, SOPs and Work instructions in compliance with regulatory and industry standards and the company's policies and procedures.
• Responsible for monitoring, investigating and assessing clinical s & pharmacovigilance related processes at global and regional levels for consistency and compliance with applicable laws and regulatory requirements.
• Define quality strategy for existing and new programs. Partner closely with project managers, leaders, and internal and external partners alike to ensure an end-to-end approach for quality management.
• Identify areas of risk (Risk Assessment) in liaison with Operations and develop appropriate audit program
• Own the end to end Client Audit/Inspections activities for sites and scope
• Coordinate with leadership to support in Quality metrics management for projects/deals.
• Establish quality and compliance activities during transition for new deals.
• Ensure data security/privacy measures are implemented in deal teams, by the delivery leads and deal compliance representatives.
• Implementation and monitoring of Information security and Quality management system controls by utilizing expertise on ISO 9001 and 27001 is mandatory
• Analysis of RCA&CAPA, monitor effectiveness checks for the same
• Client feedback: collection, collation, analysis and recommendation for improvement on client requirements.
• Support in CSV activities at iMEDGlobal & in maintenance and improvement of global BCP and DR process.
• Support in organization level data across all the functions globally to develop a dashboard specific to respective department.