NEELESH DUBEY
Quality Professional
PROFILE
Objective:
To continue my career with an
organization where I can utilize
my Technical, communicative
and administrative skills to
benefit mutual growth and
success.
Professional Summary:
• Strong verbal, written,
and Interpersonal
communication skills.
• Superb multitasker and able
to handle multiple projects
efficiently and accurately.
• Knowledge of process &
and registration of Invitro
Diagnostics and Medical
Devices.
• Knowledge in Medical
Device & In-vitro
Diagnostics Regulatory
Process.
EDUCATION QUALIFICATION:
Qualification Name of Year of Passing Grade
School/College Obtained
BACHELOR Shri D.D.Vispute Final Year 2019 First Class
OF College Of Pharmacy Third Year
PHARMACY And Research Center Second Year
(Mumbai University) First Year
HSC Terna Vidyalaya February 2015 Second Class
SSC Padua High School March 2013 First Class
WORK EXPERIENCE
Vexxa Lifescience Pvt. Ltd. {Regulatory Affairs Officer}
10th September–31st May 2020.
Prepared and Reviewed Dossiers, also worked on Renewal and Submission of
Country specific Dossiers of Sri Lanka, Myanmar, Cambodia and Philippines.
Aware of CTD as well as ACTD guidelines and worked on the Dossiers as
well.
Sylis Technologies LLP {Assistant Manager Regulatory Affairs}
1st June 2020–13th November 2021.
Preparation & Submission of dossier for In-Vitro Diagnostic Medical
Devices on CDSCO Portal.
Registration and Licensing of Medical Devices & IVDs.
Maintain the documentation process for easy accessibility.
Communicate and follow up with vendors for the document submission.
Document preparation and submission of Tenders obtained.
Valuesoft Info Services Pvt. Ltd. {Quality Professional}
15th November 2021–Present.
Working as Quality Engineer at Siemens Healthineers India Pvt.
Ltd.
Preparation & Review of Post-Market Surveillance (PMS) plans &
Reports, PSUR Reports.
Preparation & Review of Periodic Safety Update Report
(PSUR) plans & Reports.
Performance Evaluation Plan (PEP)/ Report (PER)
Good understanding of IVD documents like PER, TFI,
PSUR, PMS plan, PMCF plan & Reports.
CONTACT ACHIVEMENTS
PHONE: • Obtained Drug License and ISO Certification for Sylis
+91 7208938929 Technologies.
+91 9353132169 • Completed Training in “Q.A., Q.C. & Production”
Department. Under Qualified Officers in Bionext
pharma private limited
LinkedIn: • Attended the Annual Pharma Conference, INSIGHT
https://www.linkedin.com/in/n 2017- “Future of Pharma & Healthcare’.
eelesh- dubey-7394501a0 • Successfully submitted Dossier for IVD products and
obtained Import License.
EMAIL:
neeleshd2102@gmail.com
SKILLS:
• MS Office
• Management Skills.
• Good patience.
HOBBIES • Have an ability to work with team.
Trekking • Pressure handling
Music
Outdoor games
Traveling