AM - Quality Assurance

Jubilant Pharmova Limited

0 years

0 Lacs

Nanjangud Karnataka India

Posted:4 days ago| Platform:

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Skills Required

management sap manufacturing testing reports audit monitoring risk assessment report communication schedule frequency metrics reporting

Work Mode

On-site

Job Type

Full Time

Job Description

Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA closure of the same before the product release.
Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities within the due date.
Coordinating for complaint investigation, handling of Return Goods and Recall.
Review of contract manufacturing / testing documents such as, executed BPR and Analytical reports.
Shall be responsible for performing unplanned audit on shop floor.
Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident.
Shall be responsible for review and closure of Change control and related action items.
Shall be responsible for a rchival of change control and other related documents.
Preparation of Quality Assurance SOPs and review of plant SOPs.
Handling of change control & deviations related to warehouse & SCM.
Preparation and Review of Risk Assessment report for New Products & process change products.
Shall be responsible to preparation of risk assessment and declaration as per customer requirement and current guideline.
Review of Vendor Qualification documents as per checklist and communication to Vendors/Supply Chain Management.
Preparation of Vendor audit schedule on annual basis and implementation of schedule as per the frequency defined.
To follow and maintain formats and Annexures as per current version of SOP# QAD-SOP-0014, QAD-SOP-0054, QAD-SOP-0081, QAD-SOP-0100, QAD-SOP-0019.
Periodic updation of Approved Vendor list as per SOP.
Shall be responsible for preparation and review of Annual Product Quality Report (APQR) Periodic Product Quality Report (PPQR) for all the products as per SOP / schedule.
Shall be responsible for preparation and review of Product Quality metrics for the products manufactured at the site.
Shall be responsible for review of process validation protocol and report.
Shall be responsible for preparation and review of cleaning validation protocol and report.
Shall be responsible for work assigned by reporting Manager.
In the absence of the position holder operational responsibilities delegated to Direct reports or designee.
Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA closure of the same before the product release.
Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities within the due date.
Coordinating for complaint investigation, handling of Return Goods and Recall.
Review of contract manufacturing / testing documents such as, executed BPR and Analytical reports.
Shall be responsible for performing unplanned audit on shop floor.
Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident.
Shall be responsible for review and closure of Change control and related action items.
Shall be responsible for a rchival of change control and other related documents.
Preparation of Quality Assurance SOPs and review of plant SOPs.
Handling of change control & deviations related to warehouse & SCM.
Preparation and Review of Risk Assessment report for New Products & process change products.
Shall be responsible to preparation of risk assessment and declaration as per customer requirement and current guideline.
Review of Vendor Qualification documents as per checklist and communication to Vendors/Supply Chain Management.
Preparation of Vendor audit schedule on annual basis and implementation of schedule as per the frequency defined.
To follow and maintain formats and Annexures as per current version of SOP# QAD-SOP-0014, QAD-SOP-0054, QAD-SOP-0081, QAD-SOP-0100, QAD-SOP-0019.
Periodic updation of Approved Vendor list as per SOP.
Shall be responsible for preparation and review of Annual Product Quality Report (APQR) Periodic Product Quality Report (PPQR) for all the products as per SOP / schedule.
Shall be responsible for preparation and review of Product Quality metrics for the products manufactured at the site.
Shall be responsible for review of process validation protocol and report.
Shall be responsible for preparation and review of cleaning validation protocol and report.
Shall be responsible for work assigned by reporting Manager.
In the absence of the position holder operational responsibilities delegated to Direct reports or designee.
Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA closure of the same before the product release.
Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities within the due date.
Coordinating for complaint investigation, handling of Return Goods and Recall.
Review of contract manufacturing / testing documents such as, executed BPR and Analytical reports.
Shall be responsible for performing unplanned audit on shop floor.
Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident.
Shall be responsible for review and closure of Change control and related action items.
Shall be responsible for a rchival of change control and other related documents.
Preparation of Quality Assurance SOPs and review of plant SOPs.
Handling of change control & deviations related to warehouse & SCM.
Preparation and Review of Risk Assessment report for New Products & process change products.
Shall be responsible to preparation of risk assessment and declaration as per customer requirement and current guideline.
Review of Vendor Qualification documents as per checklist and communication to Vendors/Supply Chain Management.
Preparation of Vendor audit schedule on annual basis and implementation of schedule as per the frequency defined.
To follow and maintain formats and Annexures as per current version of SOP# QAD-SOP-0014, QAD-SOP-0054, QAD-SOP-0081, QAD-SOP-0100, QAD-SOP-0019.
Periodic updation of Approved Vendor list as per SOP.
Shall be responsible for preparation and review of Annual Product Quality Report (APQR) Periodic Product Quality Report (PPQR) for all the products as per SOP / schedule.
Shall be responsible for preparation and review of Product Quality metrics for the products manufactured at the site.
Shall be responsible for review of process validation protocol and report.
Shall be responsible for preparation and review of cleaning validation protocol and report.
Shall be responsible for work assigned by reporting Manager.
In the absence of the position holder operational responsibilities delegated to Direct reports or designee.

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