Ega Ashok Kumar
Quality & Compliance Expert for Pharmaceutical Industry. As a quality and compliance leader, I am passionate about ensuring that pharmaceutical products meet the highest standards of quality, safety, and efficacy.
- Role
- Manager (Medical Devices) in Quality Department at Ipharmed Services
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Ega Ashok Kumar
Who am I? Quality-focused and results-driven professional with 16+ years of proven experience across the medical device and pharmaceutical industries, blending strong regulatory knowledge with deep technical expertise. Currently leading the Quality Department at IPharmed Services Pvt. Ltd, where I drive ISO 13485:2016 QMS implementation, manage audit preparedness, and oversee CAPA, market complaints, and supplier quality audits to ensure global compliance. Previously at Dr. Reddy’s Laboratories, I served as an Analytical Specialist, managing a 12-member team and overseeing end-to-end analytical support from method development and validation to regulatory submissions and product launch for US, EU, and China markets. I bring hands-on experience with HPLC, UV, IR, TLC, and a strong command of pharmacopoeial standards (USP, EP, IP, BP). My unique strength lies in bridging quality systems with technical operations, enabling faster market readiness, audit success, and sustained compliance. Passionate about leading teams, optimizing lab operations, and continuously improving systems that ensure product integrity and patient safety. ISO 13485 Lead Auditor | Diploma in Medical Device Regulatory Affairs Strong expertise in USFDA, EU-GMP, WHO compliance Cross-functional leader in quality assurance, analytical R&D, and tech transfer Known for driving audit success and elevating quality culture Open to global collaborations and leadership roles in Quality Management, Regulatory Compliance, or Analytical Sciences.
Experience
Manager (Medical Devices) in Quality Department
Sep 2024 — Present
Implementing ISO 13485-compliant Quality Management Systems (QMS), conducting mock audits, ensuring audit readiness, addressing audit observations, and driving effective CAPA implementation Managing market complaints and performing comprehensive supplier audits to uphold regulatory and quality standards Pharmaceutical Industry Skilled in conducting quality audits, performing EU-GMP gap assessments, and providing strategic support and response during USFDA inspections to ensure full regulatory compliance
Education
Osmania University
Master's degree, Organic Chemistry
Global Institute of Regulatory Affairs
Diploma , Medical Device Regulatory Affairs
Osmania University
Bachelor's degree, Chemistry
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