Priyanka Dileep Tulsiani

· Functioned as a QA Operational Lead for review of Intermediates, Drug Substance, and Drug Product EBRs, generation of batch release documentation for ~ 50 lots in collaboration with technical stakeholders fulfilling commercial forecasts

· Led timely assessments of Temperature Excursions to ensure smooth clinical trials and support batch disposition for 300 events in alliance with 4 cross- functional teams, drove SOP developments and executed process improvements

· Identified internal/external KPI's for all Quality Systems to be presented for Quality Management Review meetings, assisted in defining and further refining scope of data, risks, standardized KPIs and SOP revisions

· Developed a new process for Annual Product Review (APR) oversight, adapted process owner responsibilities to ensure comprehensive manufacturing data review/ feedback and accomplishing established standards for 2 consecutive years

· Executed handling of ~40 commercial and clinical complaints, adapted process owner responsibilities to drive complaint investigations to completion and analyzed data trends for recurring complaints

· Acted as a liaison between 2 business partners and FibroGen Internal audit team and executed audit requests

· Developed cleaning protocols and defined validation strategies for oral solid dosage technology for ~10 equipment

· Generated technical cleaning evaluations, including maximum allowable carryover from product to product

· Performed Environmental monitoring for 2 large scale manufacturing facilities, to support recovery studies

• Authored a Continued process verification (CPV) technical report for Caplets and Tablets to identify opportunities for process optimization and to determine the state of control of manufacturing

• Analyzed QC results for two products to author bulk- hold study summary reports and assign retest periods

· Designed Continued Process Verification (CPV) program for powder technology at two CMO's by establishing QTPP and QbD approach to ensure continuous improvement, in compliance with cGMP, Bayer SOP and ICH Q8

· Designed strategy document for RCA utilizing FMEA, FTA, and HACCP tools to assess relative severity risk for each product to improve process efficiency and effectivity

• Reviewed QA documents such as SOPs, Method Validation Protocols, Sampling Reports, BPR, MFR, Line Clearance, Change Control & Sampling Protocol for a successful validation