Htoo Htet Myat (Sarah)
Summary
Detail-oriented Quality Assurance Manager with 8 years of experience in quality assurance, product development and regulatory field of Dental and Medical Devices. Precise and proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction. Proficient in using independent decision-making skills and sound judgment to positively impact company success.
Overview
14
14
years of professional experience
Work History
Quality Assurance Manager/Technical Manager
Dentalife Australia Pty Ltd
11.2023 - Current
- Perform the quality management roll in-line with the requirements of the company QMS and ISO 13485
- Responsible for Internal and External Quality Audits across the Group.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Responsible for ensuring QMSs supports and maintain company manufacturing licenses
- Represent the company on GMP and product related issues both in-house and at external meetings, seminars or functions, etc
- Prepare, maintain and submit documentation to meet the standards required by the company quality policies and ISO13485
- Maintain company training records.
- Manage and assist in developing the QMS to meet current and future developments, ie Design & Development, Environmental Standards, License extensions, etc
- Undertake all operations in line with the Dentalife Quality System and ISO 13485 and any other quality standards required for day-to-day operations and business development
- Maintain and prepare all records and documents required and supporting both the ISO 13485 Quality Standard and new regulatory requirements identified
- Assist in the manufacture of products as directed complying with batch documentation and Work Instructions
- Ensure products developed meet safety, performance, regulatory and user need requirements as defined by company policies, target market regulatory authorities and QMS standards
- Ensures that all materials and packaging inputs and outputs to development program are compliant with the QMS (Quality Management System)
- Ensure the compliance requirements of regulatory bodies such as TGA and in ASEAN region, such as the TFDA, and apply the required quality aspects to relevant site operations
- Manage the product registration process by preparing regulatory dossier and coordinating the appropriate regulatory authorities
- Review and develop technical files for products, processes, and regulatory submissions
- Liaise with export staff (Thailand) for regulatory documentation
- Manage and report on company risk management systems as well as product risk management / design risk management report
- Conduct and report Risk Assessment analysis when required
- Assist in the preparation, analysis, and presentation of Quality indicator metrics to support Quality Review Board and Management Review Meetings
- Perform product quality review as required
- Reduced defects in products by conducting thorough inspections and identifying areas for improvement.
- Streamlined testing processes by introducing automated tools, increasing efficiency and reducing errors.
- Support the compliance gap management activities
- Comply with Occupational Health and Safety requirements
- Enhanced product quality by implementing comprehensive QA processes and procedures.
- Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
- Implemented corrective action plans based on audit findings, resulting in measurable improvements over time.
- Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
- Established robust quality documentation systems that ensured traceability throughout the entire production lifecycle.
- Drove successful product launches with rigorous pre-release testing protocols that minimized post-launch issues.
- Mentored junior staff members in best practices for quality management, contributing to overall team growth and development.
Managing Director/Marketing Manager
ZEZE Beauty And Healthcare
06.2019 - Current
- Facebook E-Commerce Business to re-sell cosmetics, beauty and healthcare products to Myanmar
- Boosted sales performance through the creation of engaging promotional materials and targeted advertising strategies.
- Managed social media accounts for optimal audience engagement and increased online presence.
- Analyzed market trends to identify new opportunities, adjusting marketing plans accordingly for maximum effectiveness.
- Negotiated partnerships with key influencers, maximizing brand exposure in target markets.
- Conducted thorough competitor analysis to stay ahead of industry trends and maintain a competitive edge in the market space.
- Managed budgets, allocating funds strategically towards high-impact initiatives that supported overall business goals.
- Researched developing trends to stay updated with new ideas and marketing practices.
Research and development manager
Dentalife Australia Pty Ltd
01.2020 - 10.2023
- Responsible for the innovation of new products and improvement of existing products for commercialization to ensure Dentalife’s maintains its premium brand position
- Maximized project efficiency by streamlining processes and implementing innovative research strategies.
- Research and Development associate plan, organize, direct, control and coordinate research and development activities within the organization
- Perform research and development operations in compliance with conformity and regulatory standards as defined in ISO 13485 or drug GMP standards
- Reduced research costs through meticulous resource allocation and budget management.
- Enhanced product quality by identifying gaps in existing research methodologies and implementing improvements.
- Increased team productivity with effective prioritization, organization, and time management practices.
- Conduct research and development activities and operations as required by the company Design & Development procedures
- Collaborated cross-functionally to drive innovation and integrate new technologies into development processes.
- Ensure products developed meet safety, performance, regulatory and user need requirements as defined by company policies, target market regulatory authorities and QMS standards
- Implements the Design & Development procedures and plan to ensure the company develops products that meet the standards of quality and performance as defined in the QMS
- Document activities, experiments, findings, research and publish results on research projects as required by the company Design & Development procedures
- Ensures that all materials and packaging inputs and outputs to development program are compliant with the QMS (Quality Management System)
- Managed a diverse portfolio of projects, balancing priorities to achieve timely completion and desired outcomes.
- Fostered a culture of continuous improvement by promoting open communication, feedback, and learning opportunities within the team.
- Manage the product registration process by preparing regulatory dossier and coordinating the appropriate regulatory authorities
- Assess the benefits and monitoring the costs and effectiveness of research and development activities and preparation quarterly summary report
- Provide input to work instructions to support the implementation of manufacturing site operations
- Review and develop technical files for products, processes, and regulatory submissions
- Manage and report on company risk management systems as well as product risk management / design risk management report
- Established strong relationships with external partners to secure necessary resources for successful project execution.
- Implemented risk mitigation strategies to minimize potential obstacles during the project lifecycle.
- Evaluated competitor products to identify areas for differentiation and potential competitive advantages in new developments.
- Improved overall R&D operations by standardizing reporting methods and data management systems.
- Support in secured funding for critical research initiatives through persuasive grant proposals and presentations.
- Created process recipes and conducted statistical analysis to define specifications and determine equipment capabilities.
- Liaised with key stakeholders to understand business requirements and expectations and develop strategic direction to R&D performance materials.
Research and development associate
Pharmadesign co., ltd / dentalife Australia Pty Ltd
11.2018 - 12.2019
- Responsible for developing new products as well as improving current formulations and coordinate research activities
- Implements the Design & Development procedures and plan to ensure the company develops products that meet the standards of quality and performance as defined in the QMS (quality management system) and must comply with ISO (International organization for standardization) 13485 for medical device products including dental products
- Ensure all experimental activities and findings are documented and report as required by the company Design & Development procedure and provide advice on research projects
- Provide advice also on new product development options to the organization
- Effectively manage research projects and resource requirements
- Prepare cost estimation and benefits regarding each research projects
- Provide input to work instructions to support the implementation of operations
- Manage and report on company risk management systems and product risk analysis where required.
Quality Assurance Manager
Pharmadesign Co.,Ltd
09.2016 - 10.2018
- Enhanced product quality by implementing comprehensive QA processes and procedures.
- Reduced defects in products by conducting thorough inspections and identifying areas for improvement.
- Streamlined testing processes by introducing automated tools, increasing efficiency and reducing errors.
- Improved customer satisfaction ratings through meticulous attention to detail and consistent quality control measures.
- Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
- Collaborated with cross-functional teams to identify root causes of product issues, leading to timely resolutions and continuous improvements.
- Conducted regular audits to ensure adherence to established protocols, maintaining consistency across the organization.
- Managed supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections.
- Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
- Prevented costly recalls by proactively addressing potential risks before they escalated into larger issues.
- Implemented corrective action plans based on audit findings, resulting in measurable improvements over time.
- Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
- Established robust quality documentation systems that ensured traceability throughout the entire production lifecycle.
- Mentored junior staff members in best practices for quality management, contributing to overall team growth and development.
- Championed a customer-focused mindset across the organization by emphasizing the importance of consistently delivering high-quality products and services.
- Performed root cause analysis to identify and resolve quality issues and defects.
- Implemented new quality assurance and customer service standards.
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
Quality Assurance supervisor
Pharmadesign co., ltd / dentalife Australia Pty Ltd
06.2016 - 08.2016
- Responsible to maintain quality management system compliance with manufacturing and regulatory standards (including ISO13485 and ISO9001)
- Ensure that all the products are compliant with quality standards before released for sale
- Perform the internal audits on production, purchasing, warehousing and logistics, supplier performance, and maintain audit ready status
- Provide systems and training to ensure staff understand and operate within QMS system.
- Enhanced team performance by providing regular training, feedback, and guidance to Quality Assurance staff.
Technical Product Expert
Ni Tun Oo Trading Co., Ltd
03.2010 - 01.2012
- Responsible for doing research on competitor products on the market, preparing report of results, give advice on product development research activities and responsible for helping to educate sales and clients on new products and hospital related equipment
- Prepare contact sheet in database of key customers that are technical experts and key opinion leaders, and attend user group meetings, scientific meetings, and shows where technical support and business development is required
- Continued involvement of business development activities in areas related to new R&D projects based on expertise and need in the field.
Education
Internal Audit Course ISO13485:2016 -
BSI
2019
Introduction To Dentistry Course, “Distinction” -
Australian Dental Industry Association
2018
ISO9001:2015 Quality Mangement System Auditor/lead Auditor Course, Lloyds “Unique Delegate Number 12586 -
Lloyds
2017
Master of Science - PHARMACEUTICAL TECHNOLOGY
Chulalongkorn University
Bangkok, Thailand01.2016
Certificate in Achievement of Chemical Safety Training Held By Chemical Safety & Hazardous Waste Management Program -
Chulalongkorn University
2015
BACHELOR OF PHARMACY (B. PHARM) - Pharmacy
University of Pharmacy, Yangon
Yangon, Myanmar01.2013
DIPLOMA - INFORMATION TECHNOLOGY
National Management College
Yangon, Myanmar2013
Skills
- Technical skills/Technical support
- Project Management / Planning
- Data Collection
- Data Analysis
- Quality Control
- Quality Assurance
- Internal auditing, Audit reporting
- Systems Development
- Product Testing
- Task management, task delegation
- Performance review
- Employee Training
- Continuous Deployment
- Analyze Test Results
- Document Control
- Compliance with GMPs
- Sampling Techniques
- Team Leadership
- Operation and Control
- Microsoft Windows
- Microsoft PowerPoint
- Microsoft Project
- Microsoft Word
- Microsoft SharePoint
- Microsoft Excel
- Data Mapping
- Critical Thinking
- Teamwork and Collaboration
- Decision-Making
- Attention to Detail
- Organization and Time Management
- Excellent Communication
- Problem-Solving
- Flexible and Adaptable
Accomplishments
- Research poster presentation in Asian federation for Pharmaceutical Sciences Conference 2015 held on 25-27 November 2015
- Research poster presentation iGRC 2015 (International Graduate Research Conference) on 11th December 2015
- Oral presentation entitled “Development and Brain Delivery of Chitosan=PEG Nanoparticles Functionalized with the Monoclonal Antibody OX26”
- Seminar I - “A new methodology for high drug loading wet granulation formulation development”
- Seminar II - “Solidified the liquid formulations by spray drying” (A literature Review)
- ThesiS
- Designing spray dried nanoemulsion as vaccine adjuvanthttps://www.car.chula.ac.th/display7.php?bib=b2128185
Timeline
Quality Assurance Manager/Technical Manager
Dentalife Australia Pty Ltd
11.2023 - Current
Research and development manager
Dentalife Australia Pty Ltd
01.2020 - 10.2023
Managing Director/Marketing Manager
ZEZE Beauty And Healthcare
06.2019 - Current
Research and development associate
Pharmadesign co., ltd / dentalife Australia Pty Ltd
11.2018 - 12.2019
Quality Assurance Manager
Pharmadesign Co.,Ltd
09.2016 - 10.2018
Quality Assurance supervisor
Pharmadesign co., ltd / dentalife Australia Pty Ltd
06.2016 - 08.2016
Technical Product Expert
Ni Tun Oo Trading Co., Ltd
03.2010 - 01.2012
Internal Audit Course ISO13485:2016 -
BSI
Introduction To Dentistry Course, “Distinction” -
Australian Dental Industry Association
ISO9001:2015 Quality Mangement System Auditor/lead Auditor Course, Lloyds “Unique Delegate Number 12586 -
Lloyds
Master of Science - PHARMACEUTICAL TECHNOLOGY
Chulalongkorn University
Certificate in Achievement of Chemical Safety Training Held By Chemical Safety & Hazardous Waste Management Program -
Chulalongkorn University
BACHELOR OF PHARMACY (B. PHARM) - Pharmacy
University of Pharmacy, Yangon
DIPLOMA - INFORMATION TECHNOLOGY
National Management College
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