Sreenath Konanki

About Sreenath Konanki

THE VALUE I BRING With over 21 years of experience in Pharmaceutical and Biotech Quality Assurance, I have a track record of outstanding results through professional and interpersonal skills including strategic vision, team development, people management, prioritization & grit. I have in-depth understanding of Quality functioning for creation of an organization with improved efficiency with small, mid-scale and large pharma companies. This extensive experience uniquely qualifies me to act in an advisory capacity to pharmaceutical companies and provide insightful strategic guidance for navigation of complex challenges in Quality. MY LEADERSHIP STYLE By balancing emotional intelligence, servant leadership style, and a win-win philosophy, I can build bridges between cross-functional teams and understand unique motivational needs of individuals to provide opportunities for growth and development. I drive prompt conflict resolution focused on what’s right for the organization versus who’s right. A FEW CAREER HIGHLIGHTS • Built & led large and small teams, managed budget up to $4 million• Significant Experience in setting up Quality systems and procedures from small scale to commercial manufacturing stage. • Strong Experience in Quality systems of various dosage forms: OSD, Injectable, Biologics, Medical devices, Nasal Sprays, Inhalation products, Ophthalmic, Drug-device combination products. MY AREAS OF EXPERTISE• Building and leading high performing, motivated, engaged and efficient teams• Scale-up and Technology transfer, Equipment, facility, Utility Qualification, designing Validation Master Plans and Site Master plans. Managing Validation Life cycles. • Biologics, Small and Large volume Injectables, Inhalation Products (MDI & DPI), Nasal Sprays, Drug-Device Combination products, Medical Devices, OSD, Topicals, Transdermal products.• A thorough knowledge of Quality Systems like CAPA, Change controls, Deviations, non-conformances, RCA, market complaints, stability program management, product trending and statistical analyses, conducting and managing vendor audits, Internal audits, CMO and CRO audits. • Organizing Quality Review meetings to align Quality functions and Quality metrics.• Good understanding on regulatory compliance of USFDA 21 CFR Part 210/211, 820, 11, ICH, EU GMP Annex 4 & 11, WHO, PIC/s. • Strong Experience in implementing pFMEA, Design Development Plan (DDP), Design Transfer, Design History Files (DHF) in compliance with 21 CFR Part 820. MY CONTACT INFORMATIONNetwork with me here or at s••••••••@gmail.com

Experience

1. Director Quality Assurance and Compliance

   Aurobindo Pharma USA, Inc.

   Jan 2025 — Present

Education

• Sri Krishnadevaraya University

  Bachelor of Science - BS, Microbiology

  1998 — 2001

• Bharathidasan University (BDU), Tiruchirappalli

  MPhil (MS), Biotechnology

  2006 — 2010

• Sri Krishnadevaraya University

  Doctor of Philosophy - PhD, Biotechnology

• Sri Krishnadevaraya University

  MS, Microbiology

  2003 — 2005