As a CSV Senior Partner in ERA Sciences, I am a strategic contributor across the four pillars of data reliability excellence | Data Integrity | Application Lifecycle Management | Risk | Stakeholder Management. I am focused on delivering practical and realistic high-quality solutions for clients within the Life Sciences, Medtech, and Biotech sectors to support their data reliability needs across the GXP data Lifecycle. I strive to achieve value driven outcomes that are compliant with… Show more As a CSV Senior Partner in ERA Sciences, I am a strategic contributor across the four pillars of data reliability excellence | Data Integrity | Application Lifecycle Management | Risk | Stakeholder Management. I am focused on delivering practical and realistic high-quality solutions for clients within the Life Sciences, Medtech, and Biotech sectors to support their data reliability needs across the GXP data Lifecycle. I strive to achieve value driven outcomes that are compliant with current and emerging regulatory expectations such as>FDA 21 CFR Part 11>EudraLex Volume 4 Annex 11>GAMP 2nd Edition>Anticipated changes to regulations including adoption of CSA approaches, Annex 11 Revision, AI Governance Show less

As a Validation Engineer, my role is to plan, create, and execute tests that check if a company’s manufacturing equipment produces products that meet performance, quality, and industry-specific safety standards. My understanding of manufacturing processes and data analysis helps me to prevent and fix issues, working with management to improve the company’s manufacturing processes.

Responsible for transforming client’s business models through improving the organization’s position or profile by identifying core challenges and opportunities, recommending strategies for optimization, and often implementing those strategies to create sustainable change. Scope of competencies includes: Good Manufacturing Practices, Good Distribution Practices, Good Engineering Practices and Good Laboratory Practices across the life science industry.

Responsible for conducting quality-related activities to deliver consistent, high quality documents, services, products and processes. Achieved by providing compliant solutions to a variety of problems of moderate to intermediate scope and complexity, while maintaining awareness of standards that regulate the medical device industry. Achievements•Worked with the quality and engineering functions as validation, compliance and quality support for the new Covid-19 diagnostic tests kit… Show more Responsible for conducting quality-related activities to deliver consistent, high quality documents, services, products and processes. Achieved by providing compliant solutions to a variety of problems of moderate to intermediate scope and complexity, while maintaining awareness of standards that regulate the medical device industry. Achievements•Worked with the quality and engineering functions as validation, compliance and quality support for the new Covid-19 diagnostic tests kit launches in response to the Covid-19 pandemic. •Operated as the Subject Matter Expert for Temperature Mapping requirements of local and global level scope. •Preformed activities associated with external regulatory audits by presenting and fulfilling multiple tasks requested by the auditors as part of the audit assessment and review process.•Achieved internal awards for Pioneering and A3 Problem Solving.•Coordinated quality decisions between different quality, risk and engineering functions to develop and modify validation packages, design plans, risk management deliverables, CAPA deliverables and periodic validation reviews. Show less

Responsible for developing, gathering and disseminating technical information into supporting documentation, used for the commissioning, qualification & validation of newly designed/built automation machinery.Achievements• Supported activities related to an external ISO 9001 Quality Management System Surveillance Audit by performing requested tasks relevant to the audit assessment and review process. • Engaged in an internal company audit to assess for process conformity… Show more Responsible for developing, gathering and disseminating technical information into supporting documentation, used for the commissioning, qualification & validation of newly designed/built automation machinery.Achievements• Supported activities related to an external ISO 9001 Quality Management System Surveillance Audit by performing requested tasks relevant to the audit assessment and review process. • Engaged in an internal company audit to assess for process conformity, evaluate performance, and identify processes that require improvement to ensure that the ISO 9001 Quality Management System remains fully implemented as well as completed preparations for external audits.• Aided business continuity by liaising directly with customers and stakeholders to meet demands relevant to the preparation of CQV technical documentation. Show less

Responsible for the development and execution of validation activities for equipment, processes, facilities and systems. Validation and quality work-stream delegate for various site level and global level projects.Achievements • Work stream delegate for a serialization project at both site and global level to meet the requirements of the new FMD.• Identified quality discrepancies within various temperature controlled systems and rectified the situations with relevant corrective… Show more Responsible for the development and execution of validation activities for equipment, processes, facilities and systems. Validation and quality work-stream delegate for various site level and global level projects.Achievements • Work stream delegate for a serialization project at both site and global level to meet the requirements of the new FMD.• Identified quality discrepancies within various temperature controlled systems and rectified the situations with relevant corrective actions. Quality risks were mitigated through quality reviews, risk assessments, implementing preventative measures and effectiveness checks.• Coordinated a number of temperature studies on simulated loads to investigate the consequences of uncontrolled conditions. Show less

Responsible for coordinating production, inspection and verification activities on manufacturing lines for product assemblies. Quality delegate for internal Lean 6 Sigma projects. Achievements• Identified continuous improvement opportunities within production activities for various manufacturing lines and used lean 6 sigma tools to reduce waste and increase line efficiency.• Liaised with a project manager to plan and implementation a Kanban system for… Show more Responsible for coordinating production, inspection and verification activities on manufacturing lines for product assemblies. Quality delegate for internal Lean 6 Sigma projects. Achievements• Identified continuous improvement opportunities within production activities for various manufacturing lines and used lean 6 sigma tools to reduce waste and increase line efficiency.• Liaised with a project manager to plan and implementation a Kanban system for inventory.• Consistently developed and reviewed documents for compliancy with documentation control & management procedures. Show less

ResponsibilitiesTested, monitored and evaluated machinery, equipment, processes and inventory to ensure conformity to validation criteria. Risk assessment activities, new product design and introduction, Lean 6 Sigma events, medical device inspection and documentation reviews. Quality and validation delegate to medical device R&D projects.Achievements• Identified discrepancies for three manufactured products using Lean Quality Tools and successfully eliminated each gap thus… Show more ResponsibilitiesTested, monitored and evaluated machinery, equipment, processes and inventory to ensure conformity to validation criteria. Risk assessment activities, new product design and introduction, Lean 6 Sigma events, medical device inspection and documentation reviews. Quality and validation delegate to medical device R&D projects.Achievements• Identified discrepancies for three manufactured products using Lean Quality Tools and successfully eliminated each gap thus ensuring the company was in a sound position for any audits.• Successfully built prototypes for a new innovative catheter design to be used for clinical trials under strict deadlines.• Efficiently completed all installation, operational and process protocols and reports as well as all risk assessments required for bringing a new product from design phase into production.• Received White Belt Certification for successful completion of Lean Training using GROWTTH program materials sponsored by Freudenberg and thus applied my knowledge to reduce the amount of rejects produced on a particular line using 5S principles. Show less

Responsibilities Responsible for educating students according to the framework outlined in the National Thai Curriculum. Private tutoring of all levels, from kindergarten to corporate international professionals.Administration duties such as; examination grading, registration, curriculum planning, seminar planning, lecturing materials and extracurricular planning.Achievements ● Developed a new curriculum for the module ‘English for Communication’ in the Faculty of Social… Show more Responsibilities Responsible for educating students according to the framework outlined in the National Thai Curriculum. Private tutoring of all levels, from kindergarten to corporate international professionals.Administration duties such as; examination grading, registration, curriculum planning, seminar planning, lecturing materials and extracurricular planning.Achievements ● Developed a new curriculum for the module ‘English for Communication’ in the Faculty of Social Sciences and Humanities with a team of teachers and professors.● Improved the standard of English within the Faculty through leading extra-curricular activities such as seminars, workshops and clubs for Thai Teachers and students.● Made science engaging to primary level students by organising national field trips and developed small interactive activity books for each trip to keep students fully engaged. Show less

Responsibilities Preformed scientific procedures and produced accurate results within acceptable time frames under customers quality systems while adhering to Lancaster Laboratories policies and standardsAchievements• Efficiently conducted routine microbial analysis and QC samples under tight deadlines.• Ensured that all documentation was completed on time and all recorded data was accurate, legible and conformed to the relevant quality standards.• Identified errors… Show more Responsibilities Preformed scientific procedures and produced accurate results within acceptable time frames under customers quality systems while adhering to Lancaster Laboratories policies and standardsAchievements• Efficiently conducted routine microbial analysis and QC samples under tight deadlines.• Ensured that all documentation was completed on time and all recorded data was accurate, legible and conformed to the relevant quality standards.• Identified errors, took corrective actions to eliminate errors and established preventative measures to ensure errors were not repeated. Show less

Responsibilities Used a wide range of analytical and scientific techniques to perform routine analytical tests on a large range of bio/pharmaceutical and medical devices as per customer requests. These tests included endotoxin test, preserve efficacy test, microbial limits test, cyto-toxicity test, disinfectant test, bioburdens and growth promotion test. Other duties performed included Media and equipment sterilization, environmental monitoring and equipment calibration… Show more Responsibilities Used a wide range of analytical and scientific techniques to perform routine analytical tests on a large range of bio/pharmaceutical and medical devices as per customer requests. These tests included endotoxin test, preserve efficacy test, microbial limits test, cyto-toxicity test, disinfectant test, bioburdens and growth promotion test. Other duties performed included Media and equipment sterilization, environmental monitoring and equipment calibration. Achievements • Due to demonstrating a high level of competency the company kept me on after 6 weeks of college placement.• Demonstrated an ability to responsibly perform a large range of test methods.• Showed a high degree of flexibility to achieve customer satisfaction as deadlines for reports were always met. • Validated products successfully for Endotoxin testing using the Kinetic Turbidity Method. Show less