Subodhray Shah
Vadodara
Summary
A results-driven and strategic Operations Leader with over 27 years of experience in the IVD manufacturing industry. Skilled in managing and scaling manufacturing operations, ensuring strict regulatory compliance, and driving major process improvements. A certified ISO auditor with a strong background in biochemistry and medical device regulations, experienced in leading teams to achieve excellent results in cost reduction, quality management, and production efficiency.
Overview
29
29
years of professional experience
Work History
Quality Head
Siemens Healthcare Pvt. Ltd.
Vadodara
08.2022 - Current
- Managing the effective implementation of the organization's Quality and EHS Management systems.
- Directing the maintenance and continuous improvement of the Quality and EHS System to maintain ISO 9001/13485 and ISO 14001/45001 certifications.
- Handling all internal and external audit processes to ensure full regulatory compliance and readiness.
- Leading all site-level CAPA activities, from investigation to the implementation of corrective actions.
- Conducting the periodic Quality Management Review process to check and improve system effectiveness.
- Assisting in the development and monitoring of Quality Systems KPIs to meet company goals.
- Overseeing document control and training functions to ensure quality standards are met.
Production Manager
Siemens Healthcare Pvt. Ltd.
Vadodara
08.2016 - 08.2022
- Led the project to relocate the Siemens Healthineers factory, completing it 11 months ahead of schedule and with 2% budget savings.
- Directed the complete manufacturing process, from planning to execution, to meet delivery schedules and production targets.
- Checked batch manufacturing records and daily shift operations for accuracy, compliance, and product traceability.
- Led process improvement projects that reduced conversion costs and increased manufacturing output.
- Managed complaint handling, root cause analysis (RCA), and CAPA implementation for product and process improvements.
- Led and trained high-performance teams, creating a culture of accountability and continuous improvement.
- Worked with QA, QC, and R&D for analytical method development, process validation, and regulatory compliance.
Plant Manager
Lab Care Diagnostics (India) Pvt. Ltd.
Sarigam
10.2000 - 08.2016
- Managed manufacturing operations for the entire plant, leading a team of over 75 people.
- Implemented and maintained a strong QMS based on ISO 13485, ISO 9001, CE, and MDR 17 regulations.
- Obtained all necessary product licenses, plant layout approvals, and regulatory certificates for sales and marketing.
- Ensured the plant was always ready for regulatory inspections by managing licenses, product registrations, and dossiers.
- Handled all key QMS documents, including Device Master Records (DMR), Device History Records (DHR), and validation documents.
- Directed the development and validation of analytical methods for various IVD products.
QC Chemist/QA & R&D In-Charge
Accurex Biomedicals Pvt. Ltd.
Boisar
06.1996 - 09.2000
- Developed and validated analytical methods for diagnostic reagents and urine strips.
- Managed all QC operations and supported the R&D team with new product launches.
- Developed new products, including the successful conversion of older powder-based products into stable liquid versions.
Education
Master of Science (M.Sc.) - Biochemistry
North Maharashtra University
Jalgaon, IndiaBachelor of Science (B.Sc.) - Botany
North Maharashtra University
Jalgaon, IndiaSkills
- Manufacturing & Operations: End-to-End IVD Product Manufacturing, New Product Development, Technology Transfer, and Process Optimization
- Quality & Regulatory Compliance: Certified Auditor for ISO 9001, 13485, 14001, 45001 & MDSAP Expertise in CE & Medical Device Rule-2017 (MDR 17) Compliance, CAPA, Root Cause Analysis, Non-Conformance, Deviations, and Complaint Handling
- Leadership & Operations: Team Leadership, Cross-Functional Collaboration, Production Planning, Scheduling & Execution, Cost Optimization, and Project Management
- Operational Efficiency Tools: Value Stream Mapping (VSM), Structured Problem Solving (SPS)
Languages
- English
- Gujarati
- Hindi
- Marathi
Personal Information
Date of Birth: 07/09/74
Timeline
Quality Head
Siemens Healthcare Pvt. Ltd.
08.2022 - Current
Production Manager
Siemens Healthcare Pvt. Ltd.
08.2016 - 08.2022
Plant Manager
Lab Care Diagnostics (India) Pvt. Ltd.
10.2000 - 08.2016
QC Chemist/QA & R&D In-Charge
Accurex Biomedicals Pvt. Ltd.
06.1996 - 09.2000
Master of Science (M.Sc.) - Biochemistry
North Maharashtra University
Bachelor of Science (B.Sc.) - Botany
North Maharashtra University
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