Company Overview
Role Purpose
Academic Stream
Work experience (in months)
Job Responsibility and key Decisions
Team Leadership and Development
Lead daily operations of the molecular biology QC team, assigning tasks and ensuring timely completion.
Provide training, coaching, and performance feedback to team members.
Assay Management and Execution
Oversee the execution of molecular biology assays for release testing, inprocess control, and stability testing.
Review and approve protocols, raw data, and final reports.
Compliance and Quality Assurance
Ensure compliance with GMP, GLP, and internal SOPs.
Manage audit responses and implement CAPA related to molecular biology QC.
Investigation and Troubleshooting
Lead root cause analysis for OOSOOT results or assay failures.
Drive investigations and ensure correctivepreventive actions are implemented and documented.
CrossFunctional Collaboration
Collaborate with RD, QA, Regulatory, and Manufacturing teams to support product development and lifecycle management.
Support regulatory submissions by providing validated data and technical justifications.
Resource and Infrastructure Management
Ensure the availability and calibration of molecular biology instruments and reagents.
Make decisions on resource allocation, including hiring and equipment upgrades.
Documentation and Reporting
Maintain accurate records, review batch records, and ensure adherence to data integrity principles.
Prepare technical reports for management and regulatory bodies.
Continuous Improvement
Drive process improvements, assay optimization, and implementation of new technologies within the QC molecular biology group.
Stay updated on scientific advances and regulatory changes impacting molecular biology QC.