Souvik Mukherjee

About Souvik Mukherjee

Experienced Site QMS Manager at Philips India Ltd. with 18 years of expertise across the…

Experience

1. Qms Manager

   Philips

   Oct 2023 — Present · Pune, IN

   QMR : Review and Conduct Quality Management Review meetings and tracking of Open QRM actions for timely closures.• Audit Management : Coordinate with Compliance and Notifying bodies and with Central Auditing team and responsible for conducting all External and Internal audits periodically.• CAPA Management : Responsible for Investigation and implement the action plans to correct the non-conformance, thus eliminating the cause and reoccurrence of detected non-conformances. CAPA management is handelled through e-tool TrackWise.• Change Management :Responsible as a change coordinator for processing, reviewing and monitoring of Change control through e-tool ARIS Portal.• Training Management : Conduct and arrange external trainings and assign internal trainings within the departments through e-tool TEDs.• QMS Process Deployments : Responsible for deployment of current QMS processes of latest versions at site to align with Global procedures.• KPI Objective Management : Review, Conduct monthly KPI objective meetings and tracking of Open actions for timely closures.• ICQAs Management : Responsible for preparation, review and tracking of all Inter Company Quality Agreements.

Skills

• Quality Control
• Gmp
• Quality System
• V&V
• Standard Operating Procedure (Sop)
• Technology Transfer
• Biotechnology
• Environmental Monitoring
• Laboratory
• Capa
• Validation
• Glp
• U.s. Food and Drug Administration (Fda)
• Regulatory Requirements
• Microbiology
• Good Laboratory Practice (Glp)
• Quality Assurance
• Pharmaceutical Industry
• Sop
• Fda