Ruchi Shah

About Ruchi Shah

A highly motivated Quality Assurance leader with the experience working in Quality Assurance, Compliance, Quality control, TrackWise Deviations, CAPA, Change Control Requests and Auditing. Proficient with providing site metrics of all quality events, Microsoft Word, Excel, PowerPoint, and Microsoft Project. Proven skills in solution-oriented problem solving, cultivating, and fostering key relationships both internally and externally, and implementing compliant solutions.

Experience

1. Director of Quality Assurance

   Stratus Therapeutics

   May 2025 — Present

   Provided quality oversight of operations, including but not limited to batch record review, manufacturing support, QC support, deviation investigations, change controls, Quality agreements, SOP and project plans• Partnered with Technical Operations, QC, Regulatory, Supply chain, R&D to ensure alignment and support functions in executing the quality strategy/deliverables• Quality SME for significant quality/compliance issues, CAPA, OOS, OOT, Risk assessment and root cause analysis • Raw Material Release to ensure testing is carried out to support Quality approval or rejection. • Maintained integrated quality and risk scorecards across GxP vendors, implemented reassessment program for qualified vendors • Identified risk management strategies for vendors and remediated complex vendor issues.• Performed Internal and External Audits, analyzed data and audit outputs to identify trends and develop process improvements• Built and maintained expertise in the QA operations team, ensuring development of staff• Implemented a culture of continuous improvement and operational excellence• Maintained the Pharmaceutical Quality System (ICH Q10)—policies, SOPs, and training with effectiveness checks, management review, quality metrics, and knowledge management; ensure records retention compliance.• Developed and maintained Key Quality Performance Indicators for site Quality operations• Data Analysis and Monitoring of QMS Metric, temperature excursion management, develop and maintain performance dashboards for leadership meetings• Ensured that product quality issues are identified as early as possible and remedied through the corrective and preventive action system.• Reviewed and approved validation and qualification documents, support software upgrade activities

Education

• University at Albany

  Master of Business Administration (M.B.A.)

  2016 — 2018

• Vadodara jobs

  Bachelor's degree, Electrical, Electronics and Communications Engineering

  2008 — 2012

Skills

• Risk Assessment
• Lims
• Molecular Biology
• Biotechnology
• Microsoft Office
• Microsoft Access
• Pharmaceutical Industry
• Sop
• Fda
• Change Control
• Powerpoint
• Microsoft Excel
• Management
• Gmp
• Regulatory Affairs
• Life Sciences
• Validation
• Microsoft Word
• Softmax Pro
• Sharepoint
• 21 Cfr Part 11
• Microsoft Project
• Capa
• Laboratory
• Biopharmaceuticals
• Project Management