Vishal Vekariya - GMP Referent in Quality Assurance

Q: Where is Vishal based?

Vishal is based in Dresden, Germany .

Q: What languages does Vishal speak?

Vishal speaks the following languages: Gujarati (Native), Hindi (Native), English (Advanced), German (Intermediate) .

Q: How many years of experience does Vishal have?

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 3 months . Note that Vishal may not have shared all experience and actually has more experience.

Q: What is Vishal's latest experience?

Vishal's most recent position is GMP Referent in Quality Assurance - Validation Group at Menarini Von Heyden GmbH .

Q: What companies has Vishal worked for in recent years?

In recent years, Vishal has worked for Menarini Von Heyden GmbH , Intuitive Surgical Optics GmbH , and F. Hoffmann-La Roche Ltd .

Q: Which industries is Vishal most experienced in?

Vishal is most experienced in industries like Pharmaceutical , Biotechnology , and Healthcare . Vishal also has some experience in Manufacturing .

Q: Which business areas is Vishal most experienced in?

Vishal is most experienced in business areas like Quality Assurance (QA) , Product Development , and Research and Development (R&D) .

Q: What is Vishal's education?

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 .

Q: What is the availability of Vishal?

Vishal will be available full-time from April 2026 .

Recommended expert

Dresden, Germany

Experience

Jun 2023 - Present

2 years 9 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

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (3.5 years), Healthcare (0.5 years), Manufacturing (0.5 years), and Biotechnology (0.5 years).

Pharmaceutical

Healthcare

Manufacturing

Biotechnology

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (4 years), Product Development (1 year), and Research and Development (1 year).

Quality Assurance

Product Development

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

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

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Vishal based?

Vishal is based in Dresden, Germany.

What languages does Vishal speak?

Vishal speaks the following languages: Gujarati (Native), Hindi (Native), English (Advanced), German (Intermediate).

How many years of experience does Vishal have?

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 3 months. Note that Vishal may not have shared all experience and actually has more experience.

What roles would Vishal be best suited for?

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.

What is Vishal's latest experience?

Vishal's most recent position is GMP Referent in Quality Assurance - Validation Group at Menarini Von Heyden GmbH.

What companies has Vishal worked for in recent years?

In recent years, Vishal has worked for Menarini Von Heyden GmbH, Intuitive Surgical Optics GmbH, and F. Hoffmann-La Roche Ltd.

Which industries is Vishal most experienced in?

Vishal is most experienced in industries like Pharmaceutical, Biotechnology, and Healthcare. Vishal also has some experience in Manufacturing.

Which business areas is Vishal most experienced in?

Vishal is most experienced in business areas like Quality Assurance (QA), Product Development, and Research and Development (R&D).

What is Vishal's education?

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.

What is the availability of Vishal?

Vishal will be available full-time from April 2026.

What is the rate of Vishal?

Vishal's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.