Manager - 1

Position - Manager

Educational Qualification - M,Sc Microbiology

Experience -  Exposure in Microbiology QMS activities

15-16 Years of total experience)

Job Responsibilities :

Review and approval of followings :

• External / Internal Audit Documents
• CAPA
• Global CAPA
• Laboratory Event Investigation
• OOS / OOT Investigation
• Cross functional Investigation
• Unplanned Deviation Investigation
• Planned Deviation
• Change control
• Review, approve and support QMS activities. Review, support and lead training / Personnel qualification (Internal / External). Review and support regulatory inspection management. To represent the QMS activities as an auditee. Handling of new projects and it implementation. Support in Laboratory enhancement and compliance related activities. Coordinate the Inspection observation. Draft, Facilitate and ensure timely inspection response. Verification, Review and closure of Audit documents. Support plant for management of compliance activities. Collaborate with Corporate compliance group and implement global CAPA. Facilitate and review of global CAPA. Conducting departmental meeting related to CAPA. Initiation, Monitor, Review and closure of CAPA. To perform internal and external audit as an auditor.