Srinivas Yedavalli

An accomplished business leader with over ~20 years of experience across a number of Quality functions in Operations, Manufacturing, Start up plants project Quality Lead, R&D Tech services, External Quality Manufacturing, and Supplier Audit & Compliance. A proactive individual with extensive hands on experience of the pharmaceutical business including small molecules & large molecules - API Drug Substances, Finished formulations, Sterile and Biologics manufacturing with reputed Biopharmaceutical companies (Pfizer, MSD Singapore, GSK & Dr.Reddys Laboratories Ltd). Managed more than 45 regulatory agency inspections with direct participation and helped in compliance remediation activities. Has worked globally across multiple regions and cultures. Experience with new start up facilities:: Commissioning & qualifications of Three (3) startup facilities as Project Quality Lead for C&Q activities (API & 2 new Formulation facilities). Core competencies: Data integrity, QMS, QRM (Quality Risk Management), Compliance Remediation, Audit & Compliance, Quality Systems, Deviation management, Commissioning & Qualifications (Facilities, Equipment & Automation systems), Auditing experience (Regulatory audits of FDA, MHRA, Japan and ANVISA etc, Supplier assessments, 3rd party contract manufacturers)