Amandeep Kaur

Authoritative Quality Assurance Coordinator with almost 4 years experience in improving production outcomes and evangelizing for customer rights. Committed to discovering and eliminating weaknesses in manufacturing and development efforts. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Final Term paper on “Chemical product regulations of Canada”
• Case study for Premarket License Application and assisting Review Document for “Express LD Iliac Premounted Stent System Class IV Device”
• 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)”

• Experience of Performing Quality Control testing of the Radiopharmaceutical products for the Radiochemical purity of different samples and Performing the QA check to ensure the product is safe to use for patients Exposed to the different type of regulatory requirement for pharmaceutical and Radiopharmaceutical, biological and medical device, natural health product, Pesticides and non-prescription health products. Knowledge regarding the CNSC, FDA, EU and Health Canada regulatory Framework. Proficient in computer skills like MS office and research tools like PubMed, WebMd etc Able to take part in the company’s internal as well as external audits and perform the QA duties to define the problems and opportunities associated with the current as well as new regulatory framework Experience of preparing the different Radiopharmaceutical product kits Experience of inventory management and Receive the incoming cold product kits to compound and perform the release on them to use in the facility Knowledge of radiation exposure limit to the whole body and extremities and ALARA principle