Amandeep Kaur
***, * ********* ***** 416-***-**** ****.*********@*****.***
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