Experience

SCHMIDT + HAENSCH

• Germany
• Appliances, Electrical, and Electronics Manufacturing
• 1 - 100 Employee

• Working Student

  • Feb 2023 - Present

  • Assistance in bringing about Quality Management System standards (for example, ISO certifications) for the company. • Creating documentation for 21CFR Part 11 compliance, making white papers, and creating manuals for precision analytical instruments. • Carrying out a series of measurements and experiments, testing devices and user programs, etc. • Adaptation and testing of applications and software in the products, including the associated software. • Assistance in bringing about Quality Management System standards (for example, ISO certifications) for the company. • Creating documentation for 21CFR Part 11 compliance, making white papers, and creating manuals for precision analytical instruments. • Carrying out a series of measurements and experiments, testing devices and user programs, etc. • Adaptation and testing of applications and software in the products, including the associated software.



Tata Consultancy Services

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Senior Process Associate (Pharmacovigilance)

  • May 2019 - Aug 2022

  • Assist in all aspects of the collection, processing and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practices (GVP), Regulatory guidelines, company and project/program-specific procedures for spontaneous, Legal and/or post-marketing safety programs. • Capturing potential adverse events from a vague information, involving Medical Advisors to give their opinions, working on causality assessments, Listedness(CCDS), browsing DME, ASL for data capturing, using MedDRA for Preferred Term coding and analyzing multiple documents at same time with quality. • Processing and performing Quality review of ICSR in formats like xml format for EVWEB, E2B gateway, E-mail submission of CIOMS, MEDWATCH etc. • Compiling of complete narrative summaries, amendment report, nullification report, downgrade report, Identifying information to be queried and follows up until information is obtained and queries are satisfactorily resolved. • Assist in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements • Ensuring Quality standards and meet Productivity as per project/company requirement. Show less



Lupin

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Trainee Research Officer

  • Jun 2018 - Apr 2019

  Routine analysis and method development of Ophthalmic and Nasal formulations through HPLCs and other chromatographic and Spectroscopic techniques. Routine analysis and method development of Ophthalmic and Nasal formulations through HPLCs and other chromatographic and Spectroscopic techniques.



Doctors Analytical Laboratories Pvt Ltd 🇮🇳 Testing For A Better World

• India
• Research Services
• 1 - 100 Employee

• Intern

  • May 2017 - Jul 2017