Amandeep Kaur

***, * ********* ***** 416-***-**** adajar@r.postjobfree.com

Ottawa, ON, K2G3R6 linkedin.com/in/amandeep-kaur-b646ba145

SUMMARY OF QUALIFICATIONS

Detail-oriented and enthusiastic individual with graduation in Pharmacy and diploma in regulatory affairs field

Solution driven and highly accountable regulatory affairs professional with excellent written and communication skills

Strong research and interpersonal skills with the ability to work in team and as an individual

Excellent time management skills with organizing the tasks as per the priority

PROGRAM RELATED SKILLS

Exposed to the different type of submission and requirement for pharmaceutical, biological and medical device, natural health product, Pesticides and non-prescription health products

Knowledge of FDA, EU and Health Canada regulations

Proficient in computer skills like MS office and research tools like PubMed, WebMdetc

Take part in the company’s internal as well as external communication to define the problems and opportunities associated with the current as well as new regulatory framework

Able to support different license applications by developing SOP, expert contract and analyzing documentation

Knowledge about GMP standards to minimize the risk and to ensure the products are of high quality and ICH guidelines

OTHER SKILLS

Detail-oriented and goal-oriented

Time management skills

Adaptability and ability to work in fast paced environment

Quick learner

Strong Communication skills

WORK EXPERIENCE

Quality Assurance Associate June 2015-December 2015

Lumax Pharmaceutical Pvt Ltd.

Raw material quality check

Monitor the quality of the finished product by conducting various tests and inspection

Documentation and compilation of data

Report to the supervisor regarding any defect in products and outlined remediation plans to bring aberrant results into compliance with standards

Pharmacy Retail Sales Manager July 2016- November 2017

B.K medicos, India

Increased sales and customer satisfaction, met regulatory recordkeeping requirements by documenting the pharmacy log book, Organized in maintenance of stock and assist staff

ACADEMIC PROJECTS

Final Term paper on “Chemical product regulations of Canada”

Regulatory Impact Analysis Statement to PMRA for the use of “Chlorpyrifos”

Preparation of “New Drug Application for the Lipitor”

Project Charter on “Addressing the Challenges facing cervical cancer awareness in developing countries (Pilot: Sub- Saharan Africa- Kinshasa and India- Mizoram)”

EDUCATION

Regulatory affairs-Science January 2019- August 2019

Algonquin College, Ottawa, ON

Healthcare Administration January 2018- August 2018

Canadore College, Mississauga, ON

Bachelor of Pharmacy July 2012- June 2016

Rayat Bahra Institute of Pharmaceutical Sciences, India

REFERENCE

Reference will be available upon request

Contact this candidate