Job Description

Department DetailsRole Summary

• Assist in preparation for internal and external audits and inspections. Management (Communication and coordination) of regulatory/customer audits. Responsible to coordinate with CFTs in planning for readiness of Inspection, arrangement of documents, identifying the SMEs for discussion during inspection and interaction with inspectors.
• Preparation & review of external audit compliance (Regulatory/ Partners/ Customers) in co-ordination with all cross functional teams and follow up for implementation of CAPA.
• Initiation and closure of CAPA Reports for internal/regulatory/customer audits. Evaluation and effectiveness check verification of implemented regulatory/customer audit CAPA(s).
• Conduct periodic gap assessment in Quality Procedures and practices, escalate the risk factors to the function head and ensure implementation of agreed actions.
• Co-ordination with regulatory function and support in providing the required documentation to regulatory agency/customer.
• Monitoring, tracking, initiation, participation for all the QMS (Event, Change control, Market complaints, CAPA, OOS/OOT) element and its CAPA effectiveness check.
• Responsible for collection/compilation of data and conducting monthly Management review meeting (MRM). Monthly MRM review for QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
• Review and ensure that procedures revised are in line with the regulatory audit commitment.
• Review of Self Inspection/Regulatory Inspection/Customer Inspection observations for impact, coordinate with CFTs for immediate investigation, compliance response preparation and implementation.
• To identify, analysis and control of Risk.
• Establish and maintain the global quality system standards for Biologics manufacturing site.
• Review, closure, archival of QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
• To ensure GDP are followed in all documents during review, approval and closure.

Key Responsibilities

• Assist in preparation for internal and external audits and inspections. Management (Communication and coordination) of regulatory/customer audits. Responsible to coordinate with CFTs in planning for readiness of Inspection, arrangement of documents, identifying the SMEs for discussion during inspection and interaction with inspectors.
• Preparation & review of external audit compliance (Regulatory/ Partners/ Customers) in co-ordination with all cross functional teams and follow up for implementation of CAPA.
• Initiation and closure of CAPA Reports for internal/regulatory/customer audits. Evaluation and effectiveness check verification of implemented regulatory/customer audit CAPA(s).
• Conduct periodic gap assessment in Quality Procedures and practices, escalate the risk factors to the function head and ensure implementation of agreed actions.
• Co-ordination with regulatory function and support in providing the required documentation to regulatory agency/customer.
• Monitoring, tracking, initiation, participation for all the QMS (Event, Change control, Market complaints, CAPA, OOS/OOT) element and its CAPA effectiveness check.
• Responsible for collection/compilation of data and conducting monthly Management review meeting (MRM). Monthly MRM review for QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
• Review and ensure that procedures revised are in line with the regulatory audit commitment.
• Review of Self Inspection/Regulatory Inspection/Customer Inspection observations for impact, coordinate with CFTs for immediate investigation, compliance response preparation and implementation.
• To identify, analysis and control of Risk.
• Establish and maintain the global quality system standards for Biologics manufacturing site.
• Review, closure, archival of QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
• To ensure GDP are followed in all documents during review, approval and closure.

Educational QualificationsRequired Education Qualification: Bsc
Required Experience: 3 - 5 years

Biocon