Job Description

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