Title:  Senior Manager - QMS

Position : Sr.Manager (QMS)

Experience: 15 to 18 years in QA/QMS (Min 5 years as QMS lead)

Qualification - MSc /MPharma

Job Responsibilities:

• Responsible for QMS Team lead for Block
  • Hands on for Quality Management System,
    • Annual Product Review / Continued process verification
    • Investigation
    • Risk Assessment
    • Product Quality Complaints, Filed Alert Report (FAR), Quality Alert and Recall
    • Corrective Action & Preventive Action (CAPA) and Effectiveness check records.
    • Change Control, Deviation Reports, Extension Reports
    • SOPs
    • Document cell management
    • Site Master File
  • Review and approval of Quality Metrics and Quality Review Board presentation.
  • Identify and implement solution for improving existing site quality assurance systems and processes.
  • Involvement in co-ordination of activities for software like Track Wise®, EDMS, BRMS, APR software etc. at plant.
  • Responsible for ensuring all time audit readiness, Data integrity norms.
  • Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements. 
• Exposure with regulatory inspection like USFDA/MHRA/Health Canada and should have good communication and presentation skill