Shikha Doshi
Supervisor -Regulatory Affairs @ FUJIFILM Biotechnologies
About
Accomplished Quality Assurance professional with a background in regulatory compliance (FDA, PDMA, EMA) within the healthcare industry. Proven leadership in managing quality projects, leading teams, and ensuring adherence to compliance requirements in manufacturing and laboratory settings. Expertise in deviation management, CAPA implementation, GMP-compliant documentation, and supporting regulatory submissions and audits. Adept at fostering cross-functional collaboration, driving process improvements, and supporting regulatory strategies. Strong ability to quickly learn new technologies and regulatory requirements, with experience in supporting client projects and managing stakeholder relationships.
United States
College Station-Bryan Area
Biotechnology
Regulatory Intelligence, Communication, Change Management, Batch Release, Change Control, Deviation Management, Corrective and Preventive Action (CAPA), Quality Assurance, Biochemistry, Materials Science, Analytical Chemistry, Laboratory Skills, High-Performance Liquid Chromatography (HPLC), Good Manufacturing Practice (GMP), Microsoft Office, PTC Creo, R, Plant Tissue Culture, Biomaterials, FTIR
Experience
Supervisor -Regulatory Affairs
FUJIFILM Biotechnologies
Quality assurance analyst III
FUJIFILM Biotechnologies
College Station, Texas, United States
Technically skilled Quality Assurance professional with experience supporting manufacturing operations and clinical projects. Proficient in quality systems (Trackwise), data analysis, and leading quality projects for manufacturing readiness. Experience in deviation management, CAPA, auditing, and client management. Expertise in Viral gene therapy area and batch release. Adept at problem-solving and driving continuous improvement.
Senior Research Associate
KBI Biopharma
Colorado, United States
Research Associate specializing in method development and validation for LC instruments. Experienced in conducting equivalency testing, troubleshooting technical issues, and ensuring regulatory compliance. Proficient in data analysis, technical documentation, and training colleagues on various analytical systems.
QC Technical services Analyst II
Sanofi
Framingham, Massachusetts, United States
Technically skilled analyst with expertise in HPLC, protein aggregation assays, and size exclusion chromatography. Experienced in method validation, troubleshooting, and data analysis. Adept at collaborating on deviation investigations, CAPA workflows, and supporting GMP compliance.
QC Analyst
Integra LifeSciences
Plainsboro, New Jersey, United States
Quality Control Analyst proficient in testing within regulated environments (FDA, ISO 9001, 13485, CMDR, Medical Device Directives). Experienced in material characterization using FTIR, UV spectroscopy, DSC, Instron, and TOC. Skilled in testing in-process, finished goods, and stability samples.
Laboratory Assistant
New Jersey Institute of Technology
Newark , NJ.
I am supposed to conduct experiments and help understand the experiments of Physics. Interact with students and grade them. I thoroughly enjoyed it and learned a good experience.
Student
New Jersey Institute of Technology
Newark
Masters Project
New Jersey Institute of Technology
Newark
Under Dr. Murat, a research professor at Department chemical/ material engineering, NJIT. I was working from scratch to develop a bioink from tissues. I had to work on a process like decellularization.
Internship
ADANI, QUALITY CONTROL
Rajkot Area, India
Product testing via ASSAY Analysis and Volumetric Analysis, Systematic notation, Laboratory equipment and machine usage. record management and testing according to ISO rules . System validation and risk management.
Member , product design
X-Plant
Ahmedabad Area, India
Product Design, perform plant tissue cultures, Designing products before sales, Help Marketing Department , Workshop management, Completion of team projects.
Education
New Jersey Institute of Technology
Materials Science
Shikha Doshi's Contact Information
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