Sandeep Kumar Chandra

Background

About Sandeep Kumar Chandra

As a Validation Specialist, with over a decade’s international experience in quality and qualification domains, and dynamics of greenfield and brownfield projects, I am well positioned to lead, manage and build teams for commissioning, qualification and validation of Biopharmaceuticals across multiple regions and territories. I am inherently adaptable and seek to maintains the highest standards in every engineering leadership project, applying high level analysis and specialization in services throughout the project life cycle, from conceptual design through to handover. I am used to leading and guiding commissioning and qualification site teams to execute all C&Q, and believe in engaging, training and guiding individuals to comprehend quality systems and thus better implement commissioning and qualification solutions to complex projects. Quality and suitability planning and reviews are a key part of what I do, and I am used to understanding, and delivering on: URS, facility, process layouts, risk mitigation, C&Q execution and post-deployment. My specialist areas include: Qualification master plans, leveraging strategies, system boundary mark-up, and impact assessments Commissioning and Qualification of Project Tracking and SOP Leading teams for different C&Q validation units, such as utility, computer systems, process equipment, clean rooms and AHU Identification and categorization of GAPs in facility, utility, equipment, containment and regulation Planning risk mitigation and remediation paths with cross-functional SMEs Driving adherence of quality at site for SAT, FAT, C&Q, DQ IQ, OQ, PQ, traceability matrix, project change control and deviation handling. Well versed with the cGMP & Regulatory requirements(FDA, EU GMP, WHO, PIC/S, MHRA, ICH, ISPE, PDA, ASME BPE & HTM 2010). Experience in Regulatory audit facing like USFDA, ANVISA, TFDA, WHO, SFDA, ISO and Internal audit etc. Always open to fast-paced positions within dynamic biopharmaceutical organizations, in which I can apply my expansive skillset, industry awareness and track record of reliability. Please feel free to connect with me at sandeepchndr2011@gmail.com, or message me here if you want to find out about my value addition towards your project