Summary
Overview
Work History
Education
Skills
Academic Dissertation and Other Certifications
Hobbies and Interests
Languages
Declaration
Timeline
Generic

Nikita Parab

Mumbai

Summary

Biotechnology postgraduate with 6+ years of experience in Clinical Documentation, SOP Lifecycle Management, and Training Coordination within regulated GxP/GMP environments. Skilled in managing end-to-end document lifecycles, ensuring compliance, audit readiness, and cross-functional alignment.

Proficient in Veeva Vault, SAP GUI, SuccessFactors, Documentum, Power BI, Spotfire, and Excel automation (Macros, Power Query) to streamline processes and deliver data-driven insights. Recognized with multiple awards for accuracy, efficiency, and commitment to quality, particularly in supporting vaccine R&D documentation processes.

Currently seeking to leverage expertise in document control, compliance, and data-driven reporting to contribute to a leading pharmaceutical or biotechnology organization.

Overview

6
6
years of professional experience

Work History

Senior Process Associate - Life Sciences (Vaccines R&D)

Tata Consultancy Services (TCS)
Mumbai
07.2022 - 07.2025
Documentation & Compliance

➤ Managed the full lifecycle of SOPs and GxP-controlled documents, ensuring traceability and audit readiness using Veeva Vault and SAP GUI.
➤ Coordinated training schedules and compliance tracking, resulting in timely completion of assignments.
➤ Collaborated with global QA, RA, Clinical, and Business Development teams to meet regulatory documentation standards.
➤ Proficient in EDMS tools including Veeva Vault, SAP Logon, Documentum, and SuccessFactors.

Data & Reporting

➤ Maintained Power BI and Spotfire dashboards, automating Excel reports to enhance accuracy and deliver insights.
➤ Utilized advanced Excel functions (Macros, Power Query) to improve reporting efficiency.
➤ Leveraged basic SAS for generating compliance metrics and reporting analytics.

Recognition

➤ Received multiple “Star of the Month” awards for consistent high-quality performance and dedication.

Product Specialist

Labtron Equipmet
Mumbai
02.2019 - 07.2022
  • ➤ Managed customer communications, procurement, invoicing, and product delivery, ensuring smooth shipment and client satisfaction.
    Proofread and reviewed technical manuals to maintain clarity, accuracy, and compliance with documentation standards.
    ➤ Oversaw sourcing, procurement, and documentation of laboratory instruments, supporting operational and technical requirements.

Education

M.Sc. - Biotechnology

University of Mumbai
01.2018

B.Sc. - Biotechnology

University of Mumbai
01.2015

HSC -

Maharashtra State Board
01.2012

SSC -

Maharashtra State Board
01.2010

Skills

    Document Control (GxP/GMP): Extensive experience managing controlled documents and SOPs through their full lifecycle in compliance with global regulations

    EDMS Expertise: Proficient in Veeva Vault, SAP, and Documentum; supported end-to-end SOP/document migration to Veeva QualityDocs

    Training & Compliance: Coordinated training, maintained learner compliance, and ensured audit readiness

    Documentation & Review: Skilled in managing technical/clinical documents, metadata classification, and compliance reviews for accuracy and regulatory alignment

    Technical Skills: Advanced MS Office; working knowledge of Power BI and SAS

    Collaboration & Leadership: Cross-functional teamwork with QA, RA, Clinical, and Business units; trained colleagues and supported process improvements

Academic Dissertation and Other Certifications

  • MSc DissertationBiofertilizer Effect of Algae, University of Mumbai (A+ Grade)
  • Seminars & WebinarsBiotech Entrepreneurship (2018), Cancer and Biochemistry (ACBI West Zone), Intellectual Property Rights (2021)
  • Workshops – Hands-on training in ELISA, Water Analysis, Microbiology (VIVA College)
  • Certification – B1 Level, Cambridge Business English Certificate
  • Professional Experience – Customer Support Executive (JustDial.com); Sonotypist (Nidan Diagnostic)

Hobbies and Interests

  • Event management, volunteering, dance, reading, music, and sports – reflecting leadership, creativity, adaptability, and teamwork.

Languages

Marathi
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1

Declaration

I hereby declare that the information provided is accurate and complete to the best of my knowledge.

Timeline

Senior Process Associate - Life Sciences (Vaccines R&D)

Tata Consultancy Services (TCS)
07.2022 - 07.2025

Product Specialist

Labtron Equipmet
02.2019 - 07.2022

M.Sc. - Biotechnology

University of Mumbai

B.Sc. - Biotechnology

University of Mumbai

HSC -

Maharashtra State Board

SSC -

Maharashtra State Board
Nikita Parab