Grisha Dialani, M.Eng., E.I.T., Lssgb Email & Phone Number

Canada

• Spearheaded multiple projects to establish QMS for a satellite site including qualifying new production lines and supporting new process introduction within established timelines. • Devised Risk Management & Mitigation Strategies across multiple Value Improvement projects in alignment with ISO14971:2019 and ISO13485:2016 standards. • Synchronized cross-functional efforts to generate and maintain Risk Management Files [Plans, Reports, Hazard Analyses, and Failure Mode and Effects Analysis (FMEA)]. • Executed Root Cause Analysis (RCA) for Non-Conformances, Deviations and Corrective and Preventive Actions (CAPA) activities, supporting investigations and managing Disposition and Containment Actions. • Serving as Subject Matter Expert and demonstrated strong project management abilities by orchestrating risk-based strategies and collaborating across the organization to facilitate Software Verification and Validation deliverables across multiple sites. (additional responsibility) • Developed, Reviewed and Implemented Process Controls, Qualification Plans (Verification and Validation Plans), Qualification Protocols and Reports (IQ, OQ and PQ) across multiple sites. • Applied Standard Statistical Analysis and Problem-Solving Techniques to ascertain Product Acceptance and assess Process Capabilities. • Reduced QMS Documentation Review Time by 97% by developing an automated Excel spreadsheet with required macros & formulae applicable to 350+ documents and used across multiple sites thereby increasing accuracy in deliverables. • Championed DMAIC methodology for problem solving for multiple Operational Excellence projects such as design improvement, process improvement, cost reduction and product performance optimization projects. • Initiated and propelled Continuous Improvement (CI) projects to bolster quality initiatives.

Canada

This project is in association with Grand Challenges CanadaResponsibilities: Developed experimental plans and processes to synthesizeencapsulated formulations and qualitatively test the release in tea; Optimizedprocess parameters using Lean (5S & 5 whys) and Kaizen Methodologies;Validated analytical procedures to calculate loading and encapsulationefficiencies; Performed end-cup analysis; Performed HACCP Analysis;Developed SOPs for successful processes; Successfully interacted with variousIndustry Experts.Skills: Spray Drying, Encapsulation, Fortification, Prototyping, ProductDevelopment, Process Design, Scale-Up, HACCP, Analytical Skills, AcidDigestion, Microwave Digestion, ICP-OES.

As a teaching assistant for the course CHE399 : Professional Engineering Consultancy for 3rd year undergraduate students, I was primarily responsible for conducting weekly workshops with a batch of 35 students to provide an enriched learning experience. Other responsibilities included, but were not limited to, problem solving, grading and simulating the client - consultant relationship.

Maharashtra, India

Responsibilities: Drafted/Reviewed SOPs and Batch Records for process andpackaging of existing/new API formulations and cleaning of equipment; DesignedPFDs for plant operation and Assisted R&D experts in the development ofprojects through the conception to implementation stages; Providedtroubleshooting and engineering support at production site; Ensured cGMPcompliance and Performed deviation management; Participated in processoptimization and client audits and visits.Skills: Process Engineering, Process Optimization, Continuous Improvement,Good Manufacturing Practices, Good Documentation Practices, Troubleshooting,Organizational abilities, Teamwork.

Mumbai, Maharashtra, India

Responsibilities: Extract volatile and non-volatile components from CustardApple seeds using Supercritical CO2; Design Experiments; Optimize ProcessConditions; Analyze antioxidant and phenolic content; Establish processeconomics & life-cycle assessment.Skills: Design of Experiments, Supercritical Fluid Extraction, SEM Analysis, UVVisible Spectroscopy, Equipment Handling, Research Abilities, Good LaboratoryPractices

Master Of Engineering - Meng, Chemical Engineering

Bachelor Of Engineering - Be, Chemical Engineering, First Class With Distinction