SHALANI GENASAN
Quality Assurance & Regulatory Expertise
Klang
Summary
Experienced Quality Assurance Assistant Manager with more than 10 years and demonstrated history of working in the Medical Devices, Good Manufacturing Practice (GMP), Good Distributed Practice (GDP), Good Distribution Practice for Medical Devices (GDPMD), Quality Management ISO 9001, ISO 13485 and FDA (QSR) Quality System Regulation 21 CFR Part 820. Strong quality professional.
Overview
14
14
years of professional experience
2011
2011
years of post-secondary education
3
3
Languages
Work History
Assistant QA Manager
SIGMA GLOVE INDUSTRIES SDN BHD
11.2020 - Current
- Heading the Quality Assurance and Quality Control (Incoming, in process and outgoing).
- Assure production compliance to standards, regulations and manufacturing SOPs.
- Ensure quality compliance - Customer Complaint Processing (investigation, review, approval, answering customer inquiries), CAPA and Process Deviation.
- Lead and Coordinate Validation and Qualifications Program, Change Control as scheduled and according to requirements.
- Decision making for non-conforming materials/ product disposition.
- Monitoring complaint trending and data analysis to take proactive countermeasures.
- Risk assessment and hazard analysis for non-conforming materials/ products disposition.
- Preparation of Quality Manual, Standard Operating Procedures (SOP), Quality Plan, Product Specification, Risk Management Report (FMEA), Risk Assessment and Technical Files.
- Renewal of annual license (MDA, FDA, Canada, Australia, Jepun and Brazil), product listing, 510K application, PPE testing report.
- Provide input to the customer requirements on the regulatory requirements, Quality matter related and artwork review.
- Develop and implement Quality Management System (QMS) as per requirements (ISO 9001:2015, ISO 13485:2016, GDP and GMP) and customer/principal requirements.
- Coordinating company Annual Management Review Meeting (MRM) and follow – up identified action required after the meeting.
- Coordinate and maintain the Training Program sitewide as per internal SOP, regulatory requirements and principal requirements.
- Handling all certification, QMS, Customer, Supplier, GMP, Social Accountability Audits.
- Lead and Coordinate Validation and Qualifications Program as scheduled and according to requirements (GDP).
- Conduct the Internal Audit to all department annually according to requirement (QMS, GMP and Social Compliance).
- Conduct post-market activity and manage vigilance activity.
- To review new and/or existing Quality Technical Agreement with Principal as per principal requirement.
- To be contact personnel for liaise with Principal regarding any changes, audit, meeting, documentation and request according to principal requirement.
- To attend the monthly Country Business Review reporting departmental KPI, risk and compliance as per requirement ISO9001:2015, ISO13485:2016, GMP, GDP, GDPMD Principal Requirements.
- Develop and foster strong professional relationships with regulatory authorities and professional bodies.
- Provide insight and advice on all activities or matter associated with Quality Assurance System, Medical Affairs and Pharmaceutical compliance of the company.
- Supervising and providing technical support and guidance to Operation Department for Quality Assurance matter related.
Senior QA Executive
KOSSAN RUBBER INDUSTRIES IDEAL QUALITY SDN BHD
03.2017 - 11.2020
- Company Overview: Manufacturer of Patient Examination Gloves
- Preparation of Quality Manual, Standard Operating Procedures (SOP), Quality Plan, Product Specification, Risk Management Report (FMEA), Risk Assessment, Device Master Records Technical Files and Product File.
- Validation: Conduct validation and prepare protocol and reports for product and process (IQ,OQ,PQ,SQ).
- Standard and Regulatory Compliance: Planning and execution of QA strategies and procedures to assure compliance with all applicable international standards (ISO9001, ISO13485, ISO14971), regulatory requirements US FDA CFR Part 820 Quality System Regulations, Canadian Medical Device and current good manufacturing practices (cGMP) requirements.
- Developing and implementing quality management system in manufacturing industries.
- Act as a Document Controller for the company.
- Manage all external registration requirements to ensure they are met with external bodies on all matters relating to registration.
- Handling all certification, customer, supplier, GMP and other quality related audits.
- Act as internal auditor.
- Handling sample preparation for customer which request by Marketing.
- Conduct accelerating aging studies and shelf life studies to evaluate stability and life span of gloves.
- Arrange sample for Biocompatible Test and evaluate test report.
- Assist in preparing the Device History Records (DHR).
- Manufacturer of Patient Examination Gloves
Quality Engineer (Process)
SIGMA GLOVE INDUSTRIES SDN BHD
09.2013 - 03.2017
- Company Overview: Manufacturer of Nitrile, Surgical and Cleanroom Gloves.
- Validation: Conduct validation and prepare protocol and reports for product and process (IQ,OQ,PQ,SQ).
- QA Operations: Incoming material inspection; in-process and test; Pre-shipment inspection and test, Customer inspection.
- Training: Train QA operator and supervisor on their QA job scope.
- Handle Customer Complaints.
- Continual Improvement: Involve in Improvement project with Lean.
- KPI Report: Prepare KPI’s performance for quality.
- Kaizen: Involves in Kaizen activities for process improvement.
- Develop and implement processes, procedures Manual and other manual are in compliance with the company, manufactures requirement.
- Conduct internal and GMP audits.
- Coordinate in audits by external bodies and customer audits.
- Conduct calibration and verification on all the equipment either internally and external.
- Conduct shelf life studies to evaluate stability and life span of gloves.
- Manufacturer of Nitrile, Surgical and Cleanroom Gloves.
Medical Laboratory Scientist (MLS)
PATHOLOGY & CLINICAL LABORATORY (M) SDN BHD
08.2011 - 09.2013
- Specimen reception (Accepting, Processing and sorting of specimens).
- Perform quality control and calibration.
- Analyzes and prepare daily, monthly and yearly quality reports.
- Perform maintenance for machine by daily, weekly, monthly and as needed.
- Perform immunology tests.
- Monitor all devices and facility environment to ensure all work properly in within normal operational standards.
- Identify and troubleshoots problem occurs at machine and system.
- Send daily reports and data accurately and timely to HOD.
- Prepare the minutes of meeting.
- Ensure all documents and SOPs are compliance to ISO9001.
- Perform patient results verification and release into system.
- Checking the inventories of the incoming and outgoing reagents and other accessories.
- Conduct in pipette calibration for HQ and branches.
- Assist HOD in external, customer and internal audits.
- Involves in RIQAS and EQA.
- Assist in handling customer complaint.
Education
Bachelor - Biomedical Sciences
Management and Sciences University
Sijil Tinggi Persekolahan Malaysia (STPM) - undefined
SMK Methodist Klang
Sijil Pelajaran Malaysia (SPM) - undefined
SMK (P) Methodist
Skills
ISO 13485, ISO 9001, MDSAP, EUMDR, FDA, PPE Regulation EU 2016/425
Regulatory Compliance
GDP & GMP
Risk Management ISO 14971
Lead Auditor ISO 9001
Technical Documentation
Heading of External Audit, Internal Audit, Customer QMS & Social Compliance Audit
Calibration
Process Validation
Complaint Handling
Problem Solving
Quality Control and Quality Assurance Management System
Project Management
Certification & Training
- ISO 13485:2016 Medical Device Quality Management System Training
- ISO 9001:2015 Quality Management System Training
- FDA 21 CFR Part 820 Quality System Regulation
- ISO 9001:2015 Quality Management System Internal Audit Training
- Failure Mode And Effect Analysis & ISO 14971 Risk Management
- Complaint Handling
- Microsoft Excel Intermediate & Advance
- Statistical Process Control (SPC)
Professional Strength
Excellent Communication Skills
Time Management Skills
Critical Thinking : Decision Making
Flexibility & Adaptability
Confident
Self-Motivated
Timeline
Assistant QA Manager
SIGMA GLOVE INDUSTRIES SDN BHD
11.2020 - Current
Senior QA Executive
KOSSAN RUBBER INDUSTRIES IDEAL QUALITY SDN BHD
03.2017 - 11.2020
Quality Engineer (Process)
SIGMA GLOVE INDUSTRIES SDN BHD
09.2013 - 03.2017
Medical Laboratory Scientist (MLS)
PATHOLOGY & CLINICAL LABORATORY (M) SDN BHD
08.2011 - 09.2013
Sijil Tinggi Persekolahan Malaysia (STPM) - undefined
SMK Methodist Klang
Sijil Pelajaran Malaysia (SPM) - undefined
SMK (P) Methodist
Bachelor - Biomedical Sciences
Management and Sciences University