BSI VIET NAM OCT 2018

ISO 14971 Risk management for medical devices

BSI VIET NAM AUG 2018

Awareness and Internal Auditor of ISO 13485:2016

TONDUCTHANGUNIVERSITY JULY 2012– APRIL 2017

Major: Biotechnology

GPA: 2.5/4

INSTITUTE HUMAN RESOURCES TRAINING AND INTERNATIONAL COOPERATION

14MAY 2017- 04

ISO 22000/HACCP

Excellent result with score 9.5

ESCO VIETNAM COMPANY LTD

FEB 2016

Biosafety Certificate

BiosafetyAwarenessSeminaronEscoBiologicalSafetyandLaminarFlowCabinets

TOEIC 620 JULY 2015

IIG Vietnam

MEDICALDEVICESANDBIOMATERIALPLANTJSC OCT 2018 - NOW

Senior Quality Assurance Engineer

Support for Quality Assurance Manager in implementing the quality process:

- Control of Nonconforming Product

Support for Quality Assurance Manager in implementing the quality process: - Control  of Nonconforming Product Control and conduct corrective actions and preventive actions find root causes if errors are detected.

- Production controls

Participate in building and improving all manufacturing processes. Support Quality Assurance Manager to monitor and supervise all manufacturing processes.

- Design and Development

Review Design input requirements, drawing, Design verification, participate in design  review.

Review and collect transfer records of the principal consultants

- Validation of software

Validate all of the software prior to use in the quality system, manufacturing process,  control and measure in processes.

- Internal Audit

Participate in Internal Quality Auditor team.

Proceed Internal audit quarterly in each Department in the factory.

- Usability Engineering

Collect data into Usability Engineering File.

Inspect the Usability Engineering File base on BS EN 62366-1 2015

- Risk Management

Analysis risks in Quality System, Manufacturing Process, Design and Research.  Evaluate pFMEA, dFMEAcomply with ISO 14971 2012

- Validation of Process

Conduct IQ, OQ, PQ of EO Sterilization comply with ISO 11135: 2014, Moist heat

sterilization comply with ISO 17665-1:2006, Blister and Rotary Sealing comply with ISO

11607:2017.

- Analysis of Data

Compose Statistical techniques of the sampling plan and the sampling size for  inspecting incoming products, semi-products in-process, finished products. Analyze data of nonconforming products, internal audit, Feedback, Characteristics and  trends of processes and product, information related to delivery performance by SPC methods

MEDICALDEVICESANDBIOMATERIALPLANTJSC MAY 2018 - OCT2018

Quality Assurance Engineer

Support for Quality Assurance Manager in implementing the quality process:

- Control of Nonconforming Product

Control and monitor manufacturing process, make corrective actions and preventive actions if errors are detected

- Production controls

Participate in building manufacturing processes

- Design and Development

Review Design input requirements, drawing, Design verification, participate in design  review

- Validation of software

Validate all of the software prior to use in the quality system, manufacturing process,

control and measure in processes

- Internal Audit

Participate in Internal Quality Auditor

SPMCORPORATION JAN 2017 - APRIL 2018

QC Staff

Main responsibilities:

Quality Control Staff Main responsibilities:

- Analyst, quality control in SPM corporation.

- Analytic content compounds in drug comply SSOP.

- Control Microorganism quotas of pharmacy.

- Inspect suitable methods to control pharmacy.

- Good at using types of equipment in pharmaceutical.

Achievement:

- GMP, GLP, 5S Training in Oct 2017.