Thineswari Manamaran

Quality Assurance / Regulatory Affairs Executive at Biopro (M) Sdn Bhd (Brightway Holding Group), Port Klang, Malaysia

April 2019 — Present

• To ensure products manufactured or distributed comply with the required regulations, such as Food & Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA), GMP and etc. 
• To assist the Management to ensure the appropriate licensing and legal compliance of products in order to control the safety and efficacy of products. 
• Liaising with regulatory authorities and designated agents for product improvements. 
• Provide ongoing support to product development for regulatory issues and questions. 
• Keep up to date with changes in regulatory legislation, guidelines and etc. 
• Prepare and update Technical Files, FMEA, and all related regulatory documentation when necessary. 
• Conduct Internal Quality Audits covering all elements of ISO 9001, and ISO 13485, and promote quality company culture.
• Acting as a Quality Engineer to facilitate the efficient and effective processing of Nonconforming Material Reports and Rework Orders.
• Lead the quality of products and services by creating and implementing the process KPI, including pertinent quality control tests and inspections and engineering change order support.
• Lead the creation, maintenance, and performance of BMS change management tools: Corrective Action Reports (CAR’s), Preventive Action Reports (PAR’s), and Process Change Orders (PCO’s).
• Manage engineers and lab technicians by ensuring proper activities are completed in a timely manner, performed and documented correctly, and readily offer guidance and support to ensure Quality System compliance.
• Participate in the development of Management Review Presentations.
• Participate in 3rd party audit and inspection activities (ISO, FDA, etc.)
• Coordinate the creation, execution, and validation of all change orders.
• Ensure that reasonable risk management controls are in place.
• Review Work Order fulfilment activities to ensure completeness of manufacturing and assigned rework activities.
• Review Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements.

My professional experience as a QA/RA Executive in the medical devices industry spans five years, during which I have developed a comprehensive understanding of quality assurance and regulatory affairs. I have been involved in ensuring compliance with industry standards and regulations, overseeing the implementation of quality management systems, and managing regulatory submissions and audits. My role has also included collaborating with cross-functional teams to address quality issues, conducting risk assessments, and driving continuous improvement initiatives to enhance product quality and regulatory compliance.

Overall, my experience has equipped me with the skills and expertise necessary to effectively navigate the complex landscape of QA/RA within the medical devices sector.

My most relevant education is a Bachelor's degree in Chemical Engineering from UCSI University. Throughout this program, I gained a strong foundation in chemical processes, materials science, and engineering principles. While my educational background may not directly align with the medical devices industry, the analytical skills, problem-solving abilities, and attention to detail that I acquired during my studies are highly transferable and valuable in the QA/RA field.

Additionally, I have supplemented my education with relevant coursework and certifications to enhance my understanding of regulatory affairs and quality management systems within the medical devices sector.