Coordinate with cross functional teams for the preparation and review of documents.
Check SOPs are available for all quality related activities and are current.
Prepare and reviewing procedures like SOPs, Specs, MOAs, AWS, PRPs, MFR, BMRs, forms etc.
Preparation of Level-I documents.
Documentation: To assist and implementation GMP documentation.
To review and approve master batch manufacturing record, Batch processing record & Batch Packing Record.
To assist and guide issuance of BMRs and BPRs for execution of batches as per the work order and regulatory requirements.
To enforce latest development in GMP, SOPs, BMRs & BPRs etc.
QMS: Evaluation and compliance of impact assessment of change control / Deviation related to facility and documentation.
To conduct and assist risk analysis, impact analysis, GAP analysis related to facility, deviation, Change control and mitigation of them.
Investigation of deviations, market complaints through various tools and maintain CAPA with adequate root cause investigations and compliance to scheduling and completion of resulting action items
Enter Deviations & OOS are investigated and necessary Corrective and Preventive actions in the log book.
Prepare internal audits schedule and necessary Corrective and Preventive actions as per internal audits.
Review and approval of validation protocols and reports.
