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Manmath Kumar Rout is listed as Quality Assurance | Regulatory Affairs | Medical Device at KEYCARE DRUGS PVT. LTD., based in Hyderabad, Telangana, India. AeroLeads shows a matched LinkedIn profile for Manmath Kumar Rout.
Manmath Kumar Rout previously worked as QA/RA Executive at Keycare Drugs Pvt. Ltd. and QA/QC Executive-Cum-Lab In-Charge at Srt Agroscience Pvt. Ltd.. Manmath Kumar Rout holds Master Of Science, Biotechnology, 1St from North Orissa University.
Experienced Senior Quality Assurance Executive with a postgraduate degree in Biotechnology and 6+ years of experience in quality assurance, regulatory compliance, and process improvement. Currently thriving at KeyCare Drugs Pvt. Ltd., an In-Vitro Diagnostics (IVD) medical device manufacturer.I am adept at translating complex technical information into clear and concise reports, keeping leadership informed of critical QA initiatives and ensuring alignment with organizational goals.My key strengths include:• Manage compliance with relevant medical device regulations and standards (ISO 13485). Maintain and update the Quality Management System (QMS) to ensure its effectiveness.• Monitor and maintain compliance with relevant quality standards, regulations, and certifications throughout the manufacturing process.• Create QC procedures for materials, production, and testing.• Collaborate with procurement and suppliers to maintain quality standards for raw materials, conducting supplier audits and evaluations as needed.• Provide training and guidance.• Manage quality documents (SOPs, instructions, records).• Investigate quality issues (non-conformances, complaints) & implement CAPAs to prevent them.• Continuously improve manufacturing for efficiency, waste reduction, and quality.• Prepare for audits (internal (ISO 19011) /external) by keeping full docs and ensuring audit readiness. Risk Management (ISO 14971) Report: Identify and mitigate risks to quality and safety in manufacturing.• Collaborate across departments for new products, processes, and regulations.• Oversee the validation and verification of manufacturing processes & equipment. Maintain calibration report.• Promote continuous improvement across quality and manufacturing.As a highly motivated and detail-oriented QA professional, I bring a strong commitment to continuous learning and improvement. I am confident my skills and experience can be a valuable asset to any organization seeking a quality-focused and results-driven professional.
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Hyderabad, Telangana, India
QA/RA Executive, responsible for developing and monitoring QA processes, ensuring compliance with quality standards, training employees on quality procedures, reporting on quality performance, handling complaints, and liaising with external auditors.
Raipur, Chhattisgarh, India
• Managed operational documents and produced reports detailing activities.• Maintained equipment, facility, and inventory for optimal performance.• Planned or directed research, development or production activities (biofertilizers & biopesticides: liquid, powder, capsule, granule, etc.).• Updated quality control standards, methods, and procedures to meet compliance requirements & maintenance of microbial culture.• Enhanced efficiency, quality, and output in fast-paced manufacturing.• Managed and archived quality documentation and participated in internal and external quality audits. Performed root cause analysis on non-compliant parts.• Adhered to quality standards to minimize errors and maximize customer satisfaction.
Hyderabad, Telangana, India
• Assist in the creation and thorough review of medical device documents, ensuring they meet regulatory and quality standards.• Coordinated with medical experts, regulatory affairs professionals, and technical writers to streamline the creation of high-quality, compliant documents for medical devices.• Applied in-depth knowledge of medical device regulations and guidelines to review and edit documents, ensuring alignment with ISO, and other relevant standards.• Developed and enforced rigorous quality control measures for documentation processes, improving accuracy and reducing errors in medical and clinical research reporting and publications.• Interpreted complex clinical and technical data into clear reports, enhancing stakeholder understanding and decision-making.
Bhubaneswar, Orissa, India
• Worked in the project – “Standardization of various macro-propagation methods of useful wild edible fruit plants of Odisha”.• Adhered to scientific protocols to draw robust, evidence-based conclusions.• Maintained high levels of confidentiality to protect data quality and project research.• Recorded data from research to allow for accurate analysis.• Edited papers for submission to prestigious academic and peer-reviewed journals.• Collaborated with guide & other researchers to write and distribute impactful results of propagation techniques (layering, grafting, seedling, and stem cutting etc.), nursery & disease-pest management research.
Activities and Societies: Workshop on Molecular Biology Techniques (HI-MEDIA), NOU, Odisha (Jan - 2018). Dissertation – Biotechnology.
Activities and Societies: Seminar Presentations & Workshops / Hands-on-Training
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Manmath Kumar Rout works for KEYCARE DRUGS PVT. LTD..
Manmath Kumar Rout is listed as Quality Assurance | Regulatory Affairs | Medical Device at KEYCARE DRUGS PVT. LTD..
Manmath Kumar Rout is based in Hyderabad, Telangana, India while working with KEYCARE DRUGS PVT. LTD..
Manmath Kumar Rout has worked for Keycare Drugs Pvt. Ltd., Srt Agroscience Pvt. Ltd., Pulsus Healthtech Ltd, and Regional Plant Resource Centre.
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Manmath Kumar Rout holds Master Of Science, Biotechnology, 1St from North Orissa University.
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