Job Description
Job Responsibility and key Decisions
Overall QMS responsibility of manufacturing operations and facility management.
Ensure compliance GMP, GXP with appropriate SOPs as per regulated market requirements
Ensure compliance with appropriate SOPs, 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.