Shine Kumar

Background

About Shine Kumar

Anassiduous, aspiring & dynamic Senior Management Professional, offering 21+ years of versed & augmented experience in Instrumentation /Automation Engineering, Commissioning/Qualification/Validation, Computer System Validation, Mechanical Maintenance, Process/Packaging Engineering, Project Management, Quality Management System, Capex/Opex Management, Quality Management, Regulatory Compliance, Supplier Management, and People Management. WHERE CAN I ADD VALUE I am a seasoned pharmaceutical industry expert with a laser focus on engineering operations for both oral dosage form and sterile Fill & Finish processes. Throughout my career, I've been at the forefront of driving excellence in pharmaceutical processes, maintenance, instrumentation/automation, computerized system validation, and engineering projects & quality management systems, Commissioning/Qualification/Validation. My contributions extend to key roles in engineering activities related to production and packing machines, instrumentation/automation, quality management systems, engineering projects, and mechanical and electrical upgrades. I bring proficiency in handling a wide array of systems and instruments, including PLC, HMI, DCS, SCADA, control systems, datalogging systems, calibration, UPS, VFDs, and IoT platforms such as Track & Trace and Vision Inspection systems. In the realm of pharmaceutical engineering, I bring a strong background in cGxP & GAMP validations, including Computerized System Validation (CSV), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), among others. My proficiency extends to various pharmaceutical machinery, SAP-controlled systems, Building Management Systems (BMS) and Building Automation Systems (BAS), oral dosage process and packing machines, sterile fill and finish machines, Inspection systems, HVAC, lyophilizers, and GMP washers. A significant part of my expertise lies in quality management systems, where I've successfully managed change controls, CAPAs, deviations, investigations, audit responses, and ensured unwavering regulatory compliance. Additionally, I've served as a subject matter expert in regulatory audits, including those conducted by USFDA, MHRA, TGA, and Health Canada, where I've played a pivotal role in ensuring compliance through effective Corrective, Preventive and troubleshooting Actions (CAPAs) using SAP PM module. Do reach me out at:shineshinekumar01@gmail.com