Deputy Manager | QA – Biosimilars | Biocon Biologics | Bengaluru

Role Summary

• QMS Management
• Batch Release
• Audit Support
• Documentation function oversight

Key Responsibilities

• Review of Self Inspection/Regulatory Inspection/Customer Inspection observations for impact, coordinate with CFTs for immediate investigation, compliance response preparation, and implementation.
• Conduct periodic gap assessments in Quality Procedures and practices, escalate the risk factors to the function head and ensure implementation of agreed actions.
• Review of Documentation practices, document issuance procedures, review procedures for completeness of information, file labeling and archival systems periodically, and ensure documents prepared are readily retrievable.
• Responsible to coordinate with CFTs in planning for the readiness of Inspection, arrangement of documents, identifying the SMEs for discussion during the inspection, and interacting with inspectors.
• Assessment of change controls for impact and review of mitigation plans for risk identified, ensure changes are implemented timely and closed.
• Assessment of Deviations for Impact, Investigation mechanism, and root cause analysis for logical and scientific aspects.
• Quality metrics preparation and trend analysis
• Monthly review meeting presentation and escalation of risks associated with quality events.
• Tracking of quality events for potential overdue and ensuring timely completion of the investigation.
• Ensure CAPA’s proposed are adequate to prevent re-occurrence or occurrence
• Impart training to QA and CFTs on GxP

Educational Qualifications

Required Education Qualification: B.pharma
Required Experience: 12 – 15 years