Job Description

Department DetailsRole Summary

• Overall QMS responsibility of manufacturing operations and facility management.
• Ensure compliance (GMP, GXP) with appropriate SOP's as per regulated market requirements
• Ensure compliance with appropriate SOP's, policies and guidelines for operations in manufacturing plant
• Monitor performance metrics, draw conclusions, and make recommendations in the manufacturing review meeting (MRM) forum
• Identifying compliance issues and product quality issues and championing solutions
• To Identify risks and escalate them to the department head and relevant functional heads.
• Identifying needs for performance improvement and interacting with users and training departments
• Responsible for identification of repeat and overdue QMS events and ensure proper CAPA is in place to stop such events
• To review all , Protocols and other closure reports and ensure they comply to regulatory audits.

Key Responsibilities

• Overall QMS responsibility of manufacturing operations and facility management.
• Ensure compliance (GMP, GXP) with appropriate SOP's as per regulated market requirements
• Ensure compliance with appropriate SOP's, policies and guidelines for operations in manufacturing plant
• Monitor performance metrics, draw conclusions, and make recommendations in the manufacturing review meeting (MRM) forum
• Identifying compliance issues and product quality issues and championing solutions
• To Identify risks and escalate them to the department head and relevant functional heads.
• Identifying needs for performance improvement and interacting with users and training departments
• Responsible for identification of repeat and overdue QMS events and ensure proper CAPA is in place to stop such events
• To review all , Protocols and other closure reports and ensure they comply to regulatory audits.

Educational QualificationsRequired Education Qualification: B.Tech
Required Experience: 0 - 7 years

Biocon