Handling Overall Management of Vendors: Raw Material and Packaging Materials and Managed in SAP.
Handling of Contract Service Provider
Facilitate for timely preparation, review and adequate response to the Observation and monitor CAPA planner for it timely closures.
Monitoring and tracking of various compliance actions arises due to regulatory inspections and external audits.
Responsible for monitoring of cGMP activities at site and to have the oversight, monitoring and compliance with quality system.
To share and implement learning from internal/external audits, guidelines, Global Standards through specific training programs to improve cGMP and incorporate them in site SOPs
To perform gap assessment and revision of procedure as needed for Implementation of GQSs/GSOPs related to department and lead the Training function for the department
Handling of Internal and External Quality Audit.
Review and support for inspection management.
Lead the role of scribe in the regulatory and External inspection
Management of inspection team and SMEs during inspection
Monitoring of site risk assessment periodically for compliance
Job Requirements
Educational Qualification
MSc
Experience
3+ years
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Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).