Sukumar M

Manager - R & D Molecular Biology @Transasia Biomedicals Ltd.

Role: Manager at Transasia Bio-Medicals Ltd.
Location: Visakhapatnam, AP, IN
LinkedIn followers: 500 followers

Manufacturing & ProductionView LinkedIn profile

About Sukumar M

Enthusiastic Molecular Biologist with a comprehensive skill set encompassing technical…

Experience

Manager
Transasia Bio-Medicals Ltd.
May 2022 — Present · Visakhapatnam, IN
Design, develop, and validation of Real-Time PCR in vitro diagnostic (IVD) kits to ensure accuracy and reliability. Identify and assess technical issues through troubleshooting and risk analysis to maintain assay integrity. Facilitate technology transfer and supervise the production of IVD kits (RT-PCR), ensuring seamless scale-up and consistency. Prepare and review Master Formulation Records (MFR) and Batch Manufacturing Records to ensure compliance and traceability. Develop and maintain Design History Files (DHF) for IVD products in accordance with regulatory requirements. Ensure all documentation aligned with regulatory guidelines, specifically ISO 13485:2016, to support quality management and compliance. Lead and coordinate cross-functional teams to achieve project milestones within established timelines

Contact information

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

Transasia Bio-Medicals Ltd.

Medical Device · 2.1K employees · Mumbai, India

Incepted in the year 1979, Transasia Bio-Medicals Ltd., is headquartered in Mumbai, India. It is recognized as India’s Largest In-vitro Diagnostic Company and offers solutions and products in Biochemistry, Hematology, Coagulation, ESR, Immunology, Urinalysis, Critical Care, Diabetes Management, Microbiology and Molecular Diagnostics. Accurate and quality diagnostics can make all the difference in patient care. With a firm belief in this adage, we have been leading the way in In-vitro diagnostics by offering a broad spectrum of diagnostic products in Clinical Chemistry, Hematology, Immunology, Blood Banking, Diabetes Management & Urinalysis while keeping pace with evolving regulations. Each of our solutions have been shaped through innovations spanning more than four decades, and garnered enormous trust - 60% of our sales have been repeat customers. That’s testimony to our quality and accurate diagnostic solutions. Today, the best-in-class hospitals and lab-chains are partnering with our In-vitro diagnostics solutions for optimizing clinician productivity, and providing accurate test results for better patient care. At the Erba-Transasia Group, we regard our customers as an equal partner in this journey towards excellence. After all, your trust in us has made us ‘India’s No.1 In-vitro Diagnostic Company’. Subscribe to our YouTube channel now: https://www.youtube.com/channel/UCwqs... Get in touch with us: http://transasia.co.in/ https://in.linkedin.com/company/trans... https://twitter.com/Transasia_1 https://www.instagram.com/transasia_biomedicals/

transasia.co.in

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