THINESHWARI MANAMARAN
Regulatory Affairs & Quality Assurance Engineer
Teluk Panglima Garang,10
Summary
Have completed Bachelor (Hons) in Chemical Engineering. Experienced and reliable Quality Assurance and Regulatory Affairs Executive, Lab Head, and Quality Control Executive with 5 years of experience working in manufacturing industries to ensure the highest quality outcomes possible. Successfully provide recommendations and solutions to improve and enhance productivity. Skilled at managing long-term quality goals and day-to-day organization. Successful at forecasting market trends and financial needs.
Overview
10
10
years of professional experience
4
4
years of post-secondary education
2
2
Certifications
4
4
Languages
Work History
Quality Assurance / Regulatory Affairs Executive, Quality Control Executive, and Lab Head
Biopro (M) Sdn Bhd
Port Klang, Selangor
04.2019 - Current
- Company Overview: Brightway Holding Group
- 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
- Expertise in analytical chemistry and laboratory instrumentation, with hands-on experience in techniques such as Ion Chromatography
- Assist in cleanroom validation and cleanroom analysis tests, ensuring compliance with regulatory standards
- Experience in water treatment plants, including conducting water quality tests to monitor and maintain system efficiency
- Provide ongoing support to product development for regulatory issues and questions, contributing to compliance and continuous improvement initiatives
- 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 fulfillment 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
- Brightway Holding Group
- Reduced product defects through thorough inspections and strict adherence to company standards.
- Enhanced team efficiency by providing comprehensive training on quality control processes and tools.
- Developed and maintained a robust document control system, ensuring accurate record-keeping of all quality-related documents.
- Improved product quality by implementing rigorous testing procedures and addressing identified issues.
- Provided expert guidance during internal audits, resulting in successful compliance with established standards and procedures.
- Participated in regular reviews of standard operating procedures to ensure alignment with current industry best practices and regulatory requirements.
- Served as a subject matter expert on quality control matters during critical project phases, providing valuable input that informed decision-making processes.
- Increased customer satisfaction with timely resolution of complaints, ensuring product consistency and reliability.
- Conducted root cause analyses to determine sources of product non-conformance, implementing corrective actions accordingly.
- Managed supplier relationships to ensure consistent delivery of high-quality raw materials, contributing to overall product excellence.
- Championed process improvements initiatives that led to reduced waste and increased operational efficiency within the department.
- Played a key role in maintaining ISO certifications by consistently adhering to regulatory requirements and industry best practices.
- Performed root cause analysis to identify and resolve quality issues and defects.
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Created and maintained quality management systems to align with industry standards.
- Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
Project Executive
Neuronst Consultation Services
Sabak Bernam, Selangor
06.2017 - 03.2019
- Implemented and managed key performance indicators (KPIs) for various operational aspects, ensuring alignment with organizational goals
- Generated insightful reports and presentations for leadership, highlighting key metrics and performance against targets
- Collaborated with cross-functional teams to integrate the production system into daily workflows, optimizing real-time monitoring and decision-making
- Managed the data preparation process using Power BI, creating visually compelling and informative dashboards
- Ensured accurate and timely data collection and reporting to support informed decision-making
- Provided training and support to operations teams on utilizing Power BI for day-to-day activities
- Developed and implemented programs to enhance safety, quality, and productivity mind-set within the operations team
- Collaborated with stakeholders to identify improvement opportunities and drove the implementation of best practices
- Monitored the effectiveness of improvement initiatives, adjusting strategies as needed
- Led initiatives to promote safety consciousness, quality awareness, and productivity mind-set among team members
- Conducted training sessions, workshops, and team-building activities to reinforce desired cultural values
- Provided leadership to team of 15, conducting business visitations, strengthening partnerships and executing market research.
- Developed and implemented project plans and budgets to ensure successful execution.
- Tracked project and team member performance closely to quickly intervene in mistakes or delays.
- Monitored project progress, identified risks and took corrective action as needed.
Project Engineer Intern
Vata VM Synergy (M) Sdn Bhd
Shah Alam, Selangor
09.2016 - 12.2016
- Reporting to Managing Director about project progress
- Assisted in conducting process and site feasibility studies for waste-to-energy projects
- Assisted in the operation and maintenance of compost plants in producing organic fertilizer
- Produced monthly reports of site project work and factory operations along with deliveries of products
- Liaise with DOE (Department of Environmental), MPOB (Malaysian Palm Oil Board), CIDB (Construction Industry Development Board), and other regulatory bodies during the execution of the project
Lab Technician Intern
Scomi Oiltools Bhd.
09.2014 - 12.2014
- Involve in properties and measurement of water-based mud (WBM) and oil-based mud (OBM)
- Involve in research and development of drilling fluid
- Involve and deliver documents based on the requirements of occupational safety and health (OSH) and management system in the drilling fluid department
Education
BEng (Hons) - Chemical Engineering
UCSI University
Cheras 09.2012 - 01.2017
Skills
Leadership Skills
Presentations
Team building
Operations management
Quality control tests
Customer complaint handling
Sampling plans
Gage R&R studies
Test method validation
Measurement system analysis
External audits
CAPA management
Product inspection
Internal audits
Corrective actions
Documentation review
Quality management systems
Preventive actions
Key Performance Indicator (KPI)
Statistical Process Control (SPC)
Six Sigma
Knowledge in ISO 13485
Knowledge in ISO 14971
Knowledge in ISO 9001
Microsoft Office (Project, PowerPoint, Word, Excel, Publisher, Access, Power BI)
Ability to Multitask
Communication Skills
Effective Time Management
Certification
Certification of Six Sigma: Green Belt, 2023, LinkedIn Learning – Project Management Institute (PMI)
Professionalmemberships
- Malaysia Board of Technologists (MBOT), Graduate Technologists (Chemical Technology), GT24091073
- Board of Engineering Malaysia (BEM), Graduate Engineer, G1211874A
- American Society for Quality (ASQ), 65954846
- Royal Society of Chemistry, 663516
Timeline
Quality Assurance / Regulatory Affairs Executive, Quality Control Executive, and Lab Head
Biopro (M) Sdn Bhd
04.2019 - Current
Project Executive
Neuronst Consultation Services
06.2017 - 03.2019
Project Engineer Intern
Vata VM Synergy (M) Sdn Bhd
09.2016 - 12.2016
Lab Technician Intern
Scomi Oiltools Bhd.
09.2014 - 12.2014
BEng (Hons) - Chemical Engineering
UCSI University
09.2012 - 01.2017