Title:  Senior Associate, Compliance

Date:  Aug 8, 2022
Location:  Sun - Billerica - Plant
Company:  Sun Pharmaceutical Industries, Inc (USA)
  • Perform in-process checks and inspections; review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released through incoming and in-process inspection process
  • Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal\customer audits. Facilitate review and support regulatory inspection management.
  • Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
  • Collaborate with Corporate compliance group and implement global CAPA.
  • Support for major health authority inspections at site and provide input and support to inspection readiness/ responses to drive consistency and clarity at the site. Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.
  • Support compliance investigations as needed, in collaboration with others at the site.
  • Perform complaint investigations through analyzing returns and reviewing batch records, and provide written reports of findings
  • Participate in compliance audits (internal and external) and correct deficiencies as required through the appropriate system
  • Interface extensively on a daily basis with all departments.
  • Perform all principle duties that affect the quality of products and services within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business