Vishal Vekariya - GMP Referent in Quality Assurance - Validation Group

Dresden, Germany

Experience

Jun 2023 - Present

2 years 8 months

Dresden, Germany

GMP Referent in Quality Assurance - Validation Group

Menarini Von Heyden GmbH

Working as a CSV (Computer System Validation) Engineer in QA
Primary focus on corporate project: implementation of the manufacturing execution system (MES)
Assisted in the planning and coordination of multiple sub-projects, maintaining project documentation
Adept validation life cycle according to GAMP 5 (URS-FS-DS-FAT-SAT-IQ-OQ-PQ) to ensure compliance with regulatory standards
Reviewed and approved master batch record (MBR) validation reports
Monitored project performance against KPIs, ensuring continuous alignment with business goals and project scopes
Managed the validation and integration of the SAP-MES interface, demonstrating a strong command of computer system validation (CSV) principles
Experienced with quality management systems, for instance TrackWise
Facilitated daily cross-departmental communication and alignment with external suppliers to ensure project milestones are met on schedule

Jun 2022 - Nov 2022

6 months

Emmendingen, Germany

Master Thesis Student in Process Engineering - New Product Introduction Manufacturing Engineering

Intuitive Surgical Optics GmbH

Facilitated process development of endoscope manufacturing
Identified critical parameters for the existing gluing process in production
Conducted lab testing of elastomer and thermoplastic material
Performed operational and performance qualification of adhesives
Created a design of experiments (DoE) for characterization of adhesives
Collaborated with suppliers for experimental research analysis
Evaluated curing, physical and optical properties with rheology and spectroscopy (UV/Vis)
Created a digital glue database to allow faster adhesive selection
Standardized storage of experimental results in a digital glue database
Provided traceability of experiments through the digital glue database

Aug 2021 - Apr 2022

9 months

Basel, Switzerland

Intern of Verification Engineering in Device and Packaging Development Department

F. Hoffmann-La Roche Ltd

Trained in GMP and validation process
Participated in GMP and non GMP projects
Characterized polymer and glass based medical devices
Developed and improved the test method for quality check of medical devices
Conducted mechanical characterization of syringe using rheology
Conducted container closure integrity (CCI) testing
Performed silicon quantification in syringes (infrared mass spectroscopy-FT-IR)
Prepared technical documentation using Microsoft Office
Designed experiments (DoE)
Performed statistical analysis using Microsoft Excel, Minitab and JMP
Supported the practical testing and characterisation of medical devices
Designed 3D fixtures for different test set-ups using Creo
Provided a summary and presentation of results in the organization and scientific circle

Summary

Detail-oriented Validation Engineer and Consultant leveraging a unique academic background in Mechanical, Chemical, and Energy Engineering along with 3+ years of Life Sciences industry experience. Highly skilled in Computer System Validation (CSV) and regulatory adherence (GxP, 21 CFR, GAMP 5, ISO 13486, Annex 15). Focused on driving operational excellence and maintaining the highest standards of data integrity and quality assurance.

Skills

Quality & Validation: Gamp 5, 21 Cfr, Annex 15, Gxp, Mbr Validation, Container Closure Integrity (Cci) Testing
Quality Management System: Trackwise
System & Software: Rheometer, Spectrometer, Ptc Creo, Solidworks
Engineering & Technical: Process Engineering, New Product Introduction (Npi), Manufacturing Engineering, Product Design Verification, Material Science
Professional Skills: Cross-functional Communication, Supplier Collaboration, Protocol Writing, Data Analysis, Hands-on Working Mentality, Independent, Problem-solving, Quick Learner, Team Player
Statistical Analysis: Minitab, Jmp
Simulation And Modelling: Aspen Hysys, Aspen Plus, Ansys Fluent

Languages

Gujarati

Native

Hindi

Native

English

Advanced

German

Intermediate

Education

Apr 2019 - Nov 2022

Otto-von-Guericke University Magdeburg

Master of Science · Chemical and Energy Engineering · Magdeburg, Germany · 2.3

Aug 2014 - Jun 2018

Gujarat Technological University

Bachelor of Engineering · Mechanical Engineering · Anand, India · 2.1

Need a freelancer? Find your match in seconds.

Try FRATCH GPT

Similar Freelancers

Discover other experts with similar qualifications and experience

Experience

GMP Referent in Quality Assurance - Validation Group

Menarini Von Heyden GmbH

Master Thesis Student in Process Engineering - New Product Introduction Manufacturing Engineering

Intuitive Surgical Optics GmbH

Intern of Verification Engineering in Device and Packaging Development Department

F. Hoffmann-La Roche Ltd

Summary

Skills

Languages

Education

Otto-von-Guericke University Magdeburg

Master of Science · Chemical and Energy Engineering · Magdeburg, Germany · 2.3

Gujarat Technological University

Bachelor of Engineering · Mechanical Engineering · Anand, India · 2.1

Similar Freelancers

Co-Founder and CEO

CSV Manager, Technical Engineering

Technical Leader

Quality Specialist

Overall Project Manager for the Global Roll-Out of a Quality and Document Management System

Driving digitalization in life sciences forward - without chaos, without excuses, but with structure.

Technical Analyst

Project Manager and Quality Specialist

Project Manager Camera Systems/Lenses

Operational Excellence Consultant

Interim Head of Risk Management and Usability

IT Project Management, Implementation of AI-Supported Software Development

Senior Quality Project Expert and Consultant in the Pharmaceutical Industry

Project management, development and system integration for the retrofit of a Uranus thermionic mass spectrometer

Consultant for development-related topics and standards

Project Lead, IT-Consultant

Data Governance Manager (Laboratory Operations) and CSV/CSA & Data Integrity

Interim Project Manager Ramp-Up Pilot Facility

QA Validation/Qualification (BioNTech)

CEO and Project Manager

Senior Program Manager Transformation Office & Consultant

Service Manager - Testing

CTA

Senior Program/Project Manager, Principal finterms

Deputy Product Owner / Rollout Manager

Document Management / Document Controlling Specialist

Manager Manufacturing Operations USP

PMO

iOS App Development (AI-based)

MDR Transition with PRRC-Function