Quality Assurance Management Specialist
Resume:
Puvaneswaran
Sasigaran
Quality Assurance
Management
Specialist
Contact
Address
Seberang Jaya, Penang
Phone
puvaneswaran2304@gmail.c
om
Skills
Audit
Document Control
Quality Management System
Internal Quality Audit
Communication Skills
Vendor Management
Microsoft Excel
Microsoft Office
Microsoft Word
PowerPoint
Time Management
Precise Quality Assurance Specialist 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 satisfaction Work History
November
2022-
Current
Quality Assurance Executive cum HOD
Transpak Industries Sdn Bhd (Penang Plant)
• To take effective role, lead and control of
Quality Department Function.
• Build a strong Quality and Reliable organization.
• Liaison 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 satisfactorily 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 performance 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
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
Bahasa Malaysia C1
Advanced
English C1
Advanced
Tamil C1
Advanced
improvement throughout the organization.
• Overall, In Charge of Quality Related matters at Penang Plant.
September
2021 –
November
2022
Quality Assurance Supervisor
Becton Dickinson Sdn. Bhd.
• 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.
May 2016 –
September
2021
Quality Assurance Executive
Kck Pharmaceutical Industries Sdn Bhd, Bayan
Lepas, Penang, Malaysia
• 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.
November
2013 – May
2016
Senior Production Technician
Kck Pharmaceutical Industries Sdn Bhd
• 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.
2013-06 -
2013-11
Pharmacy Assistant
FARMASI MEDAN SIMPANG
• Process and Receive Shipment
• Provide Customer Service
• Maintain FIFO and FEFO
• Stock inventory.
Education
2013-04 Diploma of Pharmacy/Pharmacology
Masterskill University College of Health and Science 2010-04 Secondary School (SPM)
SMK St George
Certifications
2023-01 Certified Internal Auditor
2023-06 Certified Safety and Health Coordinator
2018-05 Certified First Aider
2013-09 Certified Pharmacy Assistant
.
Contact this candidate