Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Languages
Personal Information
Timeline
Generic
HENCIA MERLYN GOMES

HENCIA MERLYN GOMES

Cuncolim

Summary

Accomplished Technical Associate excelling in meticulous documentation and project management. Expert in ensuring compliance with Good Clinical Practice, enhancing interdepartmental collaboration, and driving project delivery. Demonstrated success in protocol development and site monitoring, significantly improving study efficiency and regulatory adherence.

Overview

8
8
years of professional experience

Work History

Technical Associate

SANOFI HEALTHCARE
Verna
06.2018 - 10.2024
  • Coordinated documentation for successful CTD submission.
  • Conducted site initiation visits and monitored ongoing studies at investigator sites.
  • Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
  • Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
  • Generated necessary documents to ensure compliance with regulatory requirements.Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
  • Consistently coordinated with development teams to analyze similarity between test and reference products in vitro.
  • Selected optimal biobatches utilizing formulation and pharmacokinetic assessment.
  • Serve as BEQ coordinator managing phase 1 studies globally and locally per project needs.
  • Supervised clinical supply logistics for site/CRO when necessary.
  • Coordinate project delivery to meet deadlines and budgetary limits.
  • Created comprehensive plan for bioequivalence assessment in phase 1 clinical trials.
  • Reviewed study outlines for Bioequivalence/Bioavailability studies.
  • Checked technical documentation for accuracy according to regulatory standards.
  • Conducted risk assessments by reviewing CDP, analytical data, and clinical data.
  • Conducted safety assessments for excipients in development projects.
  • Adhered to good clinical practices, operating procedures and regulatory requirements.
  • Managed procurement of required drugs for clinical trials.

Assistant Professor

GOA COLLEGE OF PHARMACY
Panjim
01.2018 - 05.2018
  • Scheduled and coordinated academic activities for students.
  • Conducted lectures on Pharmacology, Anatomy, Health Physiology, and Clinical Pharmacokinetics.
  • Provided instruction and guidance to undergraduate and graduate students in the classroom setting.
  • Organized guest lectures from experts in the field of study to supplement course content.
  • Maintained student engagement through creative subject delivery and learning activities.
  • Assisted in developing departmental policies, procedures, and activities related to educational programs.

Junior Officer

Indoco Remedies
Verna
11.2016 - 12.2017
  • Ensured accuracy through detailed examination of BMRs and BPRs.
  • Managed preparation and completion of process validation protocols.
  • Ensured proper qualification of all instrumental systems.
  • Overseeing compliance documentation.
  • Completed successful submission of application for local FDA approval.
  • Performed comprehensive reviews of product specifications and quality assurance procedures.
  • Conducted internal audits and inspections to evaluate the effectiveness of Quality Assurance processes.
  • Provided technical support to production staff on matters related to Quality Assurance.
  • Coordinated with vendors and suppliers to obtain samples for evaluation purposes as needed.

Education

Masters in Pharmacy - Pharmacology

09.2016

Bachelors in Pharmacy -

06.2014

Skills

  • Meticulous documentation
  • Good Clinical Practice
  • Project Management
  • Understanding of laboratory procedures and equipment
  • Clinical documentation
  • Data evaluation
  • Project monitoring
  • Protocols development
  • Site monitoring
  • Interdepartmental collaboration

Accomplishments

  • Developed timeline management system to ensure timely completion of projects.
  • Developed and maintained excipient safety database to aid in product development.
  • Successfully initiated and completed 5 Phase 1 studies as BEQ coordinator.

Languages

  • English
  • Hindi
  • Marathi
  • Konkani (written / oral)

Personal Information

Date of Birth: 03/03/93

Timeline

Technical Associate

SANOFI HEALTHCARE
06.2018 - 10.2024

Assistant Professor

GOA COLLEGE OF PHARMACY
01.2018 - 05.2018

Junior Officer

Indoco Remedies
11.2016 - 12.2017

Masters in Pharmacy - Pharmacology

Bachelors in Pharmacy -

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