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India Biocon Full time

Department Details Role Summary Role Responsibilities 1 Adherence to Current Good Manufacturing Practices Good document practices 2 Any other additional responsibility assigned by Reporting Manager 3 Coordinating the Qualification and Requalification activity across all cross functions 4 Ensure to notify QMS elements to partner as applicable 5 Ensure to review and approve risk assessments report identify risks actions to reduce eliminate the risk 6 Ensure to use appropriate investigation tools for investigations and recommend appropriate CAPAs 7 Ensuring QMS audit readiness 8 Escalate any CAPA effectiveness check failures to QA head 9 Escalate regulatory and partner on any validated OOS OOAC Deviations 10 Log in archival and closure of QMS elements Changecontrol Incidents Deviation Event OOS OOT OOAC CAPA Market complaint Recall 11 Maintenance of logbooks and archival of QMS documents 12 Monitor overall Internal Audit Program and to ensure that site Quality Management System QMS is complying to the regulatory requirements 13 Monitoring of GxP in manufacturing and quality control followed by escalation of gaps associated with the practices on data 14 Monitoring tracking initiation participation for all the QMS Event Change control Market complaints CAPA OOS OOT element and its CAPA effectiveness check 15 Preparation compile summary of key metrics and collation of data for Monthly review meeting 16 Preparation review of external audit compliance Regulatory Partners Customers in co-ordination with all cross functional teams and follow up for implementation of CAPA Preparation of MOM and sharing with CFT 18 Preparation of site master file VMP as per regulatory requirements or continuous improvements 19 Prepare Trend analysis for all QMS elements and report any adverse trends 20 Prepare review and approve SOPs by reviewing the contents for cGMP and regulatory compliance and training the staff on the procedures defined in the SOP 21 Responsible for ensuring Risk Assessment are performed for all equipment s facilities computer systems utilities as applicable are executed and defined controls of GAMP requirements like audit trails data backup recovery storage and password protection is in place to ensure data integrity 2 2 Responsible for tracking and implementation of APQR recommendations 23 Review and approval of Qualification validation Key Responsibilities Role Responsibilities 1 Adherence to Current Good Manufacturing Practices Good document practices 2 Any other additional responsibility assigned by Reporting Manager 3 Coordinating the Qualification and Requalification activity across all cross functions 4 Ensure to notify QMS elements to partner as applicable 5 Ensure to review and approve risk assessments report identify risks actions to reduce eliminate the risk 6 Ensure to use appropriate investigation tools for investigations and recommend appropriate CAPAs 7 Ensuring QMS audit readiness 8 Escalate any CAPA effectiveness check failures to QA head 9 Escalate regulatory and partner on any validated OOS OOAC Deviations 10 Log in archival and closure of QMS elements Changecontrol Incidents Deviation Event OOS OOT OOAC CAPA Market complaint Recall 11 Maintenance of logbooks and archival of QMS documents 12 Monitor overall Internal Audit Program and to ensure that site Quality Management System QMS is complying to the regulatory requirements 13 Monitoring of GxP in manufacturing and quality control followed by escalation of gaps associated with the practices on data 14 Monitoring tracking initiation participation for all the QMS Event Change control Market complaints CAPA OOS OOT element and its CAPA effectiveness check 15 Preparation compile summary of key metrics and collation of data for Monthly review meeting 16 Preparation review of external audit compliance Regulatory Partners Customers in co-ordination with all cross functional teams and follow up for implementation of CAPA Preparation of MOM and sharing with CFT 18 Preparation of site master file VMP as per regulatory requirements or continuous improvements 19 Prepare Trend analysis for all QMS elements and report any adverse trends 20 Prepare review and approve SOPs by reviewing the contents for cGMP and regulatory compliance and training the staff on the procedures defined in the SOP 21 Responsible for ensuring Risk Assessment are performed for all equipment s facilities computer systems utilities as applicable are executed and defined controls of GAMP requirements like audit trails data backup recovery storage and password protection is in place to ensure data integrity 2 2 Responsible for tracking and implementation of APQR recommendations 23 Review and approval of Qualification validation Educational Qualifications Required Education Qualification M Sc Required Experience 10 - 13 years