Irin Aby Abraham
Toronto,ON
Summary
Professional Summary
- Versatile research professional with over 11 years of experience in analytical research, quality assurance, and pharmacy operations, now pivoting towards Clinical Research.
- Developed robust understanding of clinical research in fast-paced healthcare environment, managing multiple projects with precision. Demonstrated expertise in regulatory compliance and patient interaction, ensuring seamless project execution. Seeking to transition these transferable skills to new field, leveraging solid foundation in research and data analysis.
- Demonstrated expertise in compliance management, regulatory standards (GCP, GMP, ICH, USFDA)
- Strong organizational, problem-solving, and multitasking skills, with a track record in data management, research support, and participant recruitment
- Excellent communicator, adept at collaborating with cross-functional teams, delivering high-quality results, and meeting project timelines in complex, high-stakes environments.
Overview
13
13
years of professional experience
4
4
years of post-secondary education
1
1
Certification
5
5
Languages
Work History
Pharmacy Assistant
CareandHealthPharmacy
Toronto, ON
01.2022 - Current
- Assists Pharmacist in dispensing medications
- Enters Patient medical data from health records and prescription details into the pharmacy system 'Fillware'
- Processes prescription for insurance claims
- Manages Pharmacy's all administrative requirements that includes daily medication delivery arrangements, assisting and completing Drug forms, applying for Seniors Co-payment or Trillium drug benefits.
- Assists in filling and maintaining invoices and receipts required for accounting.
Sr. Research Associate
InventiaHealthcareLimited
Mumbai
01.2021 - 01.2022
- Company Overview: Nutraceuticals
- Performed Analytical tests on Nutraceutical and Food product in collaboration with the product development R&D teams
- Carried out Method Development, Method Validation on Nutraceutical Active-Ingredients as per client's requirement
- Carried out Stability Analysis of developed and transferred Active-Ingredients
- Conducted Annual and daily Instrument Calibration of instruments like Balances, UV spectro-photometer, Dissolution
- Applied and performed all the tasks as per cGLP/cGMP, SOPs and applicable FDA and ICH Guidelines
- Ensured complaint and on-time release and transfers of methods to our external manufacturing site Quality Control Team
- Nutraceuticals
Pharmacist and Proprietor
HolyCrossMedicals&IMSMedicarePVT.Ltd.
Mumbai
01.2015 - 01.2021
- Established and managed a pharmacy in compliance with the Pharmacy Council of India regulations
- Hired, trained staff, and negotiated with distributors for optimal stock pricing
- Dispensed medications, provided customer consultations, and maintained excellent service
- Managed inventory, including stock checks and timely removal of expired items
Analytical Assistant [Quality Control-Stability Operations]
JanssenIndia
Mumbai
01.2012 - 01.2015
- Conducted dissolution and assay analyses on various formulations (tablets, capsules, syrups) under SOP and cGMP guidelines
- Supported stability studies, CAPA, and quality investigations, contributing to regulatory inspections (USFDA, MHRA, EMA)
Education
Bachelors of Pharmacy -
Mumbai University
01.2008 - 01.2012
Clinical Research Programme certification - undefined
CRA school of Montreal
Skills
GCP
GMP
ICH guidelines
OOS investigations
CAPA
SOPs
REB submissions
site monitoring
investigational site qualification
LIMS
Trackwise
SAP
clinical data entry
Research sops understanding
Good clinical practices
Clinical research ethics
Clinical trial management
Documentation management
Research experience
Trial management
Electronic data capture
Data analysis
Study protocols
Records maintenance
Quality control
Certification
Effective ISO 9001 Internal Auditing Practices, Alison Empower-Education, 01/01/25, 45088290
Accomplishments
- Rewarded for the completion of a project in stringent timeline at Johnson & Johnson Ltd. Organization.
- Set up and established a new Pharmacy business (India).
Status In Canada
Permanent Resident
Timeline
Pharmacy Assistant
CareandHealthPharmacy
01.2022 - Current
Sr. Research Associate
InventiaHealthcareLimited
01.2021 - 01.2022
Pharmacist and Proprietor
HolyCrossMedicals&IMSMedicarePVT.Ltd.
01.2015 - 01.2021
Analytical Assistant [Quality Control-Stability Operations]
JanssenIndia
01.2012 - 01.2015
Bachelors of Pharmacy -
Mumbai University
01.2008 - 01.2012
Clinical Research Programme certification - undefined
CRA school of Montreal