Atul Hiware

Quality Assurance & Compliance | Specializing in CSV & QMS in Pharmaceuticals, ISO 9001 and 14001

Role: Quality Specialist at Biogenomics
Location: Pune District, MH, IN
LinkedIn followers: 500 followers

Manufacturing & ProductionView LinkedIn profile

Experience

Quality Specialist
Biogenomics
Jun 2025 — Present
Lead and coordinate ISO 9001 & ISO 14001 implementation, including gap assessments, risk analysis, process mapping, and integration into a unified IMS (Integrated Management System).Develop, review, and streamline SOPs, deviation/CAPA systems, training & competency frameworks, product recall procedures, and risk registers to ensure regulatory compliance and continual improvement.Support regulatory inspections, internal/external audits, and management reviews by maintaining robust documentation and compliance culture.Work closely with QA, QC, Engineering, Production, and IT teams to ensure end-to-end compliance and operational excellence.CSV (Computerized System Validation)

Contact information

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Work email
•••••@biogenomics.co.in
Personal email
•••••@•••••.com
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Current company

Biogenomics

Pharmaceutical Manufacturing · 292 employees · Thane, Maharashtra, India

Biogenomics is a science-driven, vertically integrated pharmaceutical company specializing in treatments for diabetes and oncology. Backed by Oman Investment Authority and guided by a team of distinguished scientists, business leaders, and experts in molecular biology, microbiology, and protein engineering, Biogenomics has in a short span of time has developed a wide portfolio of biosimilars and biotech products. As an industry pioneer, Biogenomics became the first company in India to successfully launch a biosimilar of Insulin Aspart. With a robust pipeline, the company has several additional products awaiting approval. Committed to enhancing patient outcomes globally, Biogenomics has an active clinical development program focused on advancing chemical entities and biologics for the treatment of diabetes, cancer, and other critical therapeutic areas. As a young, fast-growing biopharmaceutical firm, Biogenomics is on a path to delivering excellence in healthcare. Our mission is to enrich lives by providing high-quality, affordable drugs, ensuring patient access to expensive specialty pharmaceuticals and biologic treatments. With two new additional manufacturing facilities coming up in India and Oman, Biogenomics is poised for significant global expansion. Beginning filings in 2025, the company plans to extend its reach into North America, Europe, and other key markets, further solidifying its international presence.

biogenomics.co.in

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Experience

Quality Specialist

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