RESPONSIBILITIES:
· 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 & 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
· 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 ClinChoice & 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 & coordinate with leadership to support in Quality metrics management for projects/deals.
· Work with Global Clients in for Quality Consulting assignments; short/long term
QUALIFICATION:
The person should have experience of at least 5 yrs in Quality Assurance roles within Clinical and or Pharmacovigilance and or Data Management and or Information technology in a CRO/BPO set up