Rajbir Kaur M.S.

Regulatory Affairs and Compliance Officer

Ms. Rajbir Kaur has a M.S. in Health Management and is a trained professional engineer with 10+ years of experience focusing on QA as it pertains to pharmaceutical products. Currently, Ms. Kaur is the QA analyst for Shore Wise Consulting in Toronto. Her specific responsibilities include developing test cases and test scenarios to check the compliance of the software with AML regulation and the US Patriot Act. She manages the overall testing effort, including coordination of testing personnel and test lab resources. In addition, Ms. Kaur verifies the data stored in the database with the help of SQL queries for data validation and data verification. Also, Ms. Kaur mentors and trains other team members in the use of tools and testing principles.

Previously, Ms. Kaur served as the QA analyst for Abbvie Pharmaceuticals. Her specific responsibilities developing, reviewing/auditing, and approving project documentation associated with the SLC to support applicable federal regulatory requirements. In addition, she ensured recommended changes/improvements to support the SAP System are compliant to the internal and external policies, processes and procedures. Furthermore, she was in charge of establishing quality system requirements for the SAP System and contributing to continuous improvement efforts for the Software Quality Engineering Organization.

Previously, Ms. Kaur was the Quality Engineer for Maquet in Wayne, New Jersey where she performed quality and regulatory duties in improving a quality management system in SQE role and developed project plan for SAP system computer system validation. Specifically, in this position, she developed and reviewed Quality Control Plans, Inspection SOP's, and Process Validation protocols compliant to ISO 13485 and FDA requirements. In addition, Ms. Kaur supported the evaluation, investigation, and closure of Corrective and Preventive Actions (CAPAs) improving supplier/component and product quality.

From 2007-2009 Ms. Kaur served as the Manufacturing Design Assurance for BD Medical and Health Care in Franklin Lakes, New Jersey where she was responsible for carrying out all the Quality Engineering activities for Sustaining Engineering, Managing Change Control, Product development and product maintenance such as Quality Plans and Reliability Testing activities.

Ms. Kaur worked on FMEA's, Customer Complaints and Root Cause Investigations (CAPA), Quality Management Support Activities (QMS), Control Plans, Qualifications, Process Validations, gage R&R's along with Design Verifications and Design Reviews, and implementation of new manufacturing processes for new products.

In addition, Ms. Kaur was responsible for product design for manufacturability, customer complaints, inspection and validation throughout the development process. As the QA Engineer, Ms. Kaur ensured robust execution of the design verification, validation, risk management, and process validation activities (IQ/OQ/PQ) are carried out for all aspects of product development and Change Control activities within the business platform across the BD Medical Surgical Systems.

Overall, Ms. Kaur has extensive experience working in an FDA-regulated environment with numerous years of medical device experience. Ms. Kaur’s background as a manufacturing engineer with quality and new product duties (10+ years), product sustaining/quality engineer, supplier quality engineer, complaint investigator; and applied understanding of ISO 13485 and 21 CFR Part 820 - Quality System Regulation (QSR) makes her a natural fit as the QA Engineer for Phytosciences Consulting.