Biocon Biologics Limited Hiring Freshers & Experience for ASSOCIATE

Role Summary

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 Manufacturing Records, Batch Packing Records and Dispatch Records of Drug Products.
Review Study related documents (Protocols and Reports) for Production Drug Products.

Key Responsibilities

Responsible for In process Quality Assurance routine activity, like: Line clearance for Dispensing, Formulation, Washing, Filling, Sealing, Visual inspection and secondary packaging etc.
Responsible for Batch Release process.
Performing sampling for in process checks, Finished product analysis, reserve sample, stability Batches samples and Process validation samples.
Preparation of Presentation related to Quality Matrix such as Department Operation review, QMF, MRM, Vitaris PPTs.
Participating in Peer Review for Quality Assurance, Production Drug Products, Warehouse Drug Products, Instrumentation and Automation and Engineering and Maintenance related procedures.
Coordinating meeting for related cross-functional teams related to Peer Review.
Involving in investigations related to QA and Production activities, and implementation of CAPA as per the investigation outcomes.
Training of cross-functional teams on Quality Assurance procedures.
Initiation and review of Change Management, Deviations, CAPA and CAPA Effectiveness Check pertaining to Quality Assurance.
Review of Change Management, CAPA and CAPA Effectiveness Check for Production Drug Products, Warehouse Drug Products, Instrumentation and Automation and Engineering and Maintenance.