Development QA

Role & responsibilities

• Review of process development document, process characterization, Hold time study, process characterization, QTPP, lyophilization cycle, resin life cycle, batch process records,
• Review of analytical documents such as  method development, method qualification, standard testing procedures, Certificate of analysis, stability study data, trend evaluation, shelf life assignment, reference standard qualification and management,
• Regulatory submission document review for market product characterization and its comparison, process summary protocols and reports, draft packaging and labelling information, container closure system documentation, excipient quantification reports, critical process parameters (CPPs), and critical quality attributes (CQAs).
• Prepare, review, revise, and control standard operating procedures (SOPs) of DQA and  Lab Protocols of Equipment/ Instruments of R&D, Equipment Qualification activity
• Technology transfer document review, trial batch document review and product lifecycle management.