QA- GCC (Global Compliance Cell)

Role & responsibilities

JOB SUMMARY:

1) Responsible for coordination and maintenance of Global GxP compliance programs and the centralized Quality Management Systems (QMS) to support projects undertaken at Cliantha.

2) Participate in the development, implementation and maintenance of Global QMS and SOPs for GxP systems.

3) Compile metrics, analyze trends, identify and assure implementation of quality improvement initiatives. Assure site metrics are reported to respective site and global management.

4) Review Standard Operating Procedures (SOPs) & other QMS related documents to evaluate proposed changes against ICH GCP and applicable regulatory requirements to facilitate harmonization of processes, followed across the organization.

5) Be a part of the team that maps critical issues and known risks at system and study level, manage risk assessment and mitigation strategies along with key stakeholders.

6) Responsible to provide responses to regulatory queries and feasibility questionnaires received from client within timelines and responsible to facilitate client visit / audit and regulatory agency inspections as needed.

7) Assist to manage and maintain central database / repository for change controls, CAPA, deviations, regulatory inspections and observations etc. and evaluate to make updates/changes in QMS.

8) Stay current on regulatory & ethics updates and issue regular communications / bulletins within the organization.

Job Location: Ahmedabad