Data Integrity Projects with Major Pharma Players in India with Successful outcomes within Time frame.
. Leading role in Strategy for Retrospective review and Prospective review, Execution and Compliance.
. Data integrity Audits for sites
. Evaluation of Current Policy, Procedures and Documents management system for continuous improvement.
. GXP Compliance
. Team Building and Capability Development of Team for Projects
. Conduct Training on Data Integrity to sites. Enhancing Awareness and Sensitivity of the issue.
. To Portrays Clear and Genuine Picture of Scenario to Global Management and seeking guidance on same time to time.
. Follow up and Guidance to sites to ensure and assure compliance
. Evaluation and action on Notification to Management/FAR escalation in stability analysis
. Guiding the Cross functional Team for Compliance and update feedback to Global Management.
. Confirmation and verification of Security, Reliability, Traceability and Accuracy of Raw and Electronic Data.
. Conduct Scientific Justification for Fraudulent Data and Improper Practice and corrective action on same.
Categorization in Critical / Major / Minor for deciding the Priority in remedial actions.
. Regulatory Market cGMP / cGLP
. Quality Relationship Manager for Sites Manufacturing for US/EU market
. Gap Assessment/Risk Assessment in Quality System and Corporate SOPs
. Quality Systems Management to strengthen compliance
. Trainings and Team Development
. Monitoring of Key Quality Indicators
. Market Complaints/ Stability studies/QC Expert/Pharmacopoeial Updates
. Method Development Technology Transfers/Leading the Method validation Team
. Quality Assurance
. Documentation and Quality System
. Audits and Compliance
. Stability Studies
. Analytical Method development and Validations
Location - Goa