QC- Manager (Stability & Lab Support), Otsuka Pharma, Ahmedabad

Role & responsibilities

• Lead and manage the stability study program as per ICH guidelines.
• Plan, initiate, and monitor real-time, accelerated, and intermediate stability studies for all products.
• Ensure timely sampling, testing, and data review for all ongoing stability studies.
• Maintain and review stability protocols and reports, ensuring compliance with regulatory requirements.
• Handle stability chambers (qualification, calibration, and monitoring) and ensure 21 CFR Part 11 compliance.
• Provide managerial oversight for instrument calibration, qualification, and maintenance activities in QC lab.
• Ensure timely availability of reagents, reference standards, working standards, and lab consumables.
• Support analytical testing of RM/PM/FG and ensure smooth functioning of lab operations.
• Perform investigation and troubleshooting of analytical issues, OOS, OOT, and lab incidents.
• Ensure GMP compliance in all QC stability and lab support activities.
• Prepare and review SOPs, protocols, and laboratory documentation.
• Support regulatory inspections and audits with necessary documentation and responses.
• Initiate and review change controls, deviations, and CAPAs related to stability and lab operations.
• Participate in quality risk assessments, method transfers, and method validations.
• Drive continuous improvement initiatives for lab efficiency, error reduction, and cost control.
• Implement systems for improved turnaround time (TAT) for testing and report generation. Oversee and ensure timely calibration, qualification, and preventive maintenance of analytical instruments.
• Ensure adequate availability and management of laboratory reagents, reference standards, and working standards.
• Review and approve analytical test data, protocols, and reports ensuring regulatory compliance.
• Support lab teams during analytical method validation, method transfer, and troubleshooting of technical issues.
• Train team members on LIMS usage, functionality, and best practices.

Anee.Silas@otsukapharma.in