Puvaneswaran Sasigaran
Quality Assurance Management Specialist
Seberang Jaya, Penang,07
Summary
Precise Quality Assurance Manager 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 and organization satisfication
Overview
11
11
years of professional experience
4
4
Certifications
Work History
Quality Assurance Executive cum HOD
Transpak Industries Sdn Bhd (Penang Plant)
11.2022 - Current
- To take effective role, lead and control of Quality Department Function.
- Build a strong Quality and Reliable organization.
- Liason with HQ on matters related to Quality
- Engage with Customer on Quality Issues (CAR, Audits and etc).
- Lead and monitor product quality performance, take necessary action to meet the set target.
- Prepare periodical reports for customers and lead the monthly quality meeting.
- Generate Quality Plan, controls plan, procedures, work instruction for overall quality control and coordinate on effective implementation for such plans, procedures or instructions.
- Ensure failure analysis and evaluations are carried out satisfactory to identify the root cause and drive for closure of corrective actions for internal / external CA. Recommend and initiate continual improvement measures.
- Conduct briefing to Engineers and Other Dept HOD's on quality perfomance and quality issues during QMM.
- Responsible for QA documentation for the business line.
- Liaise with Customer and External parties during New Part Developments.
- Responsible for QMS (QMR )
- QA Representative in Non Design and Design Change Projects for Penang Plant.
- Calibration Management.
- First Article Report Review and approval..(FAIR).
- Trained employees in best practices for quality assurance, fostering a culture of continuous improvement throughout the organization.
- Overall, In Charge of Quality Related matters at Penang Plant.
Quality Assurance Supervisor
Becton Dickinson Sdn. Bhd.
09.2021 - 11.2022
- Responsible for in-progress QA Audit activities at manufacturing floor
- Liaise with production supervisors/officers/Unit managers on matters relating to quality to ensure products are manufactured to quality requirements
- Collect quality data and produce report to Management on trend analysis and resolve quality issues
- Ensure that documentations required for finished product release are prepared efficiently
- Responsible for the release of Finish Goods lots
- Perform Trainings and appraisal for sub-ordinates
- QA Representative in Non Design and Design Change Projects
- Carry Out administrative duties and special projects related to QA activities as instructed by Superiors
- Perform validation work by writing protocols, executing the protocols, performing data analysis and Final Report writing
- Responsible on complaint handling activities
- Perform customer complaint investigations according to BOP and Cooperate QA guidelines
- Responsible to ensure correct conclusions are made to complaint investigation specifically on unconfirmed and confirmed related to manufacturing or user related complaint
- Manage the process documentation of CAPA, Containment Action, Corrective Action and Effectiveness Verification
- Review and approve the quality records in Date Code File
- Organizing and involvement in Quality related events.
Quality Assurance Executive
Kck Pharmaceutical Industries Sdn Bhd
05.2016 - 09.2021
- Evaluated audit findings to implement appropriate corrective actions.
- Validated quality processes by establishing product specifications and quality attributes and updating quality assurance procedures.
- Conducted regular audits of manufacturing processes, ensuring compliance with industry regulations and company policies.
- Prepared quality documentation and reports by collecting, analyzing and summarizing information and trends.
- Achieved quality assurance objectives by contributing information and analysis to strategic plans and reviews and preparing and completing action plans.
- Served as a key liaison with regulatory agencies, successfully navigating audits and maintaining favorable relationships with representatives.
- Identified training needs and organized training interventions to meet quality standards.
- Established effective communication channels between departments involved in the product lifecycle, creating a seamless flow of information regarding quality issues or concerns.
- Evaluated vendor proposals for outsourced QA services, selecting those that met corporate objectives while maintaining cost effectiveness.
- Reduced production downtime by proactively identifying and addressing potential risks before they escalated into major issues.
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Performed root cause analysis to identify and resolve quality issues and defects.
- Investigated customer complaints and performed corrective actions to resolve quality issues.
- Recorded, analyzed, and distributed statistical information.
- Gathered data on integration issues and vulnerabilities, reported findings and recommended improvements.
Senior Production Technician
Kck Pharmaceutical Industries Sdn Bhd
11.2013 - 05.2016
- Assist production manager in accomplishing the monthly production plan
- Take relevant action to prevent contamination, cross contamination and mix up in the production area
- Conduct line clearance before start manufacturing activities as per the approved SOP
- Ensure in-process checked is conducted as per approved procedures
- Report immediately to Production Manager on any spillage, process deviation, machines breakdown, accident or near-missed and any other matter needed attention
- To calculate the production yield
- Handle finished product, printed label, and packaging materials as per approved SOP to avoid mix-up
- Ensure enough primary packaging material, secondary and printed packaging material prior scheduled activity/plan.
Pharmacy Assistant
FARMASI MEDAN SIMPANG
06.2013 - 11.2013
- Process and Receive Shipment
- Provide Customer Service
- Maintain FIFO and FEFO
- Stock inventory.
Education
Diploma of Pharmacy/Pharmacology -
Masterskill University College of Health and Science
Primary/Secondary School/"O" Level - undefined
SMK St George
Skills
Audit
Document Control
Quality Management System
Internal Quality Audit
Communication Skills
Vendor Management
Microsoft Excel
Microsoft Office
Microsoft Word
PowerPoint
Time Management
People Management
Communication
ISO Standards
Documentation Review
Customer Satisfaction
CAPA Management
Trend Analysis
Quality Systems
Risk Analysis and Mitigation
Internal Audits
Employee Supervision
Progress Reporting
Continuous Improvement
Regulatory Compliance
Controls recommendation
Excellent Communication
OPS Center
SAGE System
Kizeo System
Languages
Tamil
Native language
Bahasa Malaysia
Advanced
C1
English
Advanced
C1
Tamil
Advanced
C1
Certification
Certified Internal Auditor
Timeline
Certified Safety and Health Coordinator
06-2023
Certified Internal Auditor
01-2023
Quality Assurance Executive cum HOD
Transpak Industries Sdn Bhd (Penang Plant)
11.2022 - Current
Quality Assurance Supervisor
Becton Dickinson Sdn. Bhd.
09.2021 - 11.2022
Certified First Aider
05-2018
Quality Assurance Executive
Kck Pharmaceutical Industries Sdn Bhd
05.2016 - 09.2021
Senior Production Technician
Kck Pharmaceutical Industries Sdn Bhd
11.2013 - 05.2016
Certified Pharmacy Assistant
09-2013
Pharmacy Assistant
FARMASI MEDAN SIMPANG
06.2013 - 11.2013
Diploma of Pharmacy/Pharmacology -
Masterskill University College of Health and Science
Primary/Secondary School/"O" Level - undefined
SMK St George
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