Quality Sr Specialist, Malanpur

Role & responsibilities

1. Responsible for tracking and tracing of application for product licenses for government bodies.
2. Development of Quality Technical Agreement with approved contract laboratories, material supplier, customer or any other service provider.
3. Execution of internal audit and cGMP walk as per approved schedule.
4. Tracking and tracing of internal audit, cGMP walk, CGMP GEMBA, Self-Inspection.
5. Tracking and tracking of CAPA triggered from internal audit, cGMP walk, cGMP GEMBA, Self-Inspection, customer audit/ regulatory audit.
6. Preparation of customer and regulatory audit response and review of internal audit reports.
7. Responsible for maintaining inspection readiness documents (monthly update on List of QMS, list of rejections, list of reprocess, list of material distribution etc.).
8. Preparation of monthly quality council presentations.
9. Close monitoring of quality KPIs and making part of Quality Council.
10. Update of site master file and maintenance of various license up to date.