Vishal Vekariya-GMP Referent in Quality Assurance - Validation Group
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Experience
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
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
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
Industry experience
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Experienced in Pharmaceutical, Healthcare, Manufacturing, and Biotechnology.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Product Development, and Research and Development.
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
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
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Vishal is based in Dresden, Germany.
Vishal speaks the following languages: Gujarati (Native), Hindi (Native), English (Advanced), German (Intermediate).
Vishal has at least 4 years of experience. During this time, Vishal has worked in at least 3 different roles and for 3 different companies. The average length of individual experience is 1 year and 5 months. Note that Vishal may not have shared all experience and actually has more experience.
Based on recent experience, Vishal would be well-suited for roles such as: GMP Referent in Quality Assurance - Validation Group, Master Thesis Student in Process Engineering - New Product Introduction Manufacturing Engineering, Intern of Verification Engineering in Device and Packaging Development Department.
Vishal's most recent position is GMP Referent in Quality Assurance - Validation Group at Menarini Von Heyden GmbH.
In recent years, Vishal has worked for Menarini Von Heyden GmbH, Intuitive Surgical Optics GmbH, and F. Hoffmann-La Roche Ltd.
Vishal is most experienced in industries like Pharmaceutical, Biotechnology, and Healthcare. Vishal also has some experience in Manufacturing.
Vishal is most experienced in business areas like Quality Assurance, Product Development, and Research and Development.
Vishal holds a Master in Chemical and Energy Engineering from Otto-von-Guericke University Magdeburg and a Bachelor in Mechanical Engineering from Gujarat Technological University.
The availability of Vishal needs to be confirmed.
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Calculated based on our freelancers’ daily rates as of 25 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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