Rajendra Muddana

Experience

1. Deputy Manager

   Shilpa Biologicals Private Limited

   Jan 2025 — Present · IN

   Quality Management Systems (QMS) cGMP Compliance (EMA, PIC/S, CDSCO, WHO) Using of Software tools for QMS, Training & Documentation (AIZEN) Internal & External Audit Management Regulatory Inspection Readiness Quality Risk Management as per ICH Q10, Global Regulatory guidelines compliance (ICH, EMA, and PIC/S) to ensure product safety and industry standards Deviation, OOS, Investigation, CAPA, & Change Control Management Batch Release Data Integrity & GMP Governance Validation & Qualification (URS, DQ, IQ, OQ, PQ) Supplier Quality ManagementLead QA – QMS, Audit & Compliance and as second-in-command to QA Head. Managed end-to-end QMS elements including Deviations, CAPA, OOS, OOT, Change Controls, Investigations, and Batch Release. Successfully managed regulatory inspections (EMA, PIC/S, CDSCO, ROW markets) with zero repeat findings. Review and approve Site Master File, Validation Master Plan, Quality Manual, and key validation documents. Led Quality Risk Management activities across manufacturing operations. Review batch records, Certificates of Analysis (COA), and release documentation ensuring cGMP compliance. Managed supplier quality management, including conducting vendor audits, handling change Prepare and present quality metrics dashboards to senior leadership. Lead Technology Transfer activities ensuring smooth transition from development to commercial manufacturing. Design and execute internal audit programs and track CAPA to closure. Conduct cGMP and compliance training programsReview of documents for Compliance with 21CFR Part 11, & EU Annex11

Education

• Andhra University

  Master of Science, Microbiology, General

• Birla Institute of Technology and Science, Pilani

  Master of Technology, Operations Management and Supervision

  2018 — 2020

• Andhra University

  Master's Degree, Microbiology, General

  2009 — 2011

• Birla Institute of Technology and Science, Pilani

  Master of Technology, Pharmaceutical operation and management

Skills

• Computer Maintenance
• Leadership
• Will Power
• Communication