Job Description

Department DetailsRole Summary

• Get trained on the assigned SOP\'s & ensure the training completed on-time for self as per the curriculum.
• Performing In-process QA activities primarily routine in-process checks, line clearance as per SOP.
• Online reviewing of batch records, logbook and monitoring of manufacturing and packing activities.
• Initiation of Change Control, Deviations, and CAPA pertaining to Quality Assurance.
• Ensure adherence of compliance at Quality Assurance area (office and archival area) and to notify any non-conformities.
• Performing cGMP self-inspections including preparation of reports and follow-up CAPA.
• Working and supporting the team for internal and external audits (regulators/customers/partners).
• Ensure the Compliance to procedures in the Shop Floor
• Involve in Sampling activities and AQL checks for visual inspection activities. 13.Ensure online documentation in the Shop floor.
• Handling of issuance and control of master documents and archiving of documents.
• Familiarisation of function and activities for Quality Control, Warehouse, Engineering & Maintenance, Instrumentation & Automation and Environmental, Health & Safety.
• Review of batch records for Drug product manufacturing and packing, focusing on identification of any discrepancies in the batch processing.
• Identify any Transcriptional errors, accuracy & missing attribute in executed documents during review.
• Any other assignment given by Reporting Manager

Key Responsibilities

• Get trained on the assigned SOP\'s & ensure the training completed on-time for self as per the curriculum.
• Performing In-process QA activities primarily routine in-process checks, line clearance as per SOP.
• Online reviewing of batch records, logbook and monitoring of manufacturing and packing activities.
• Initiation of Change Control, Deviations, and CAPA pertaining to Quality Assurance.
• Ensure adherence of compliance at Quality Assurance area (office and archival area) and to notify any non-conformities.
• Performing cGMP self-inspections including preparation of reports and follow-up CAPA.
• Working and supporting the team for internal and external audits (regulators/customers/partners).
• Ensure the Compliance to procedures in the Shop Floor
• Involve in Sampling activities and AQL checks for visual inspection activities. 13.Ensure online documentation in the Shop floor.
• Handling of issuance and control of master documents and archiving of documents.
• Familiarisation of function and activities for Quality Control, Warehouse, Engineering & Maintenance, Instrumentation & Automation and Environmental, Health & Safety.
• Review of batch records for Drug product manufacturing and packing, focusing on identification of any discrepancies in the batch processing.
• Identify any Transcriptional errors, accuracy & missing attribute in executed documents during review.
• Any other assignment given by Reporting Manager

Educational QualificationsRequired Education Qualification: Bsc
Required Experience: 4 - 7 years

Biocon