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Regulatory Affairs-#157

Client Information

100-500

Our client is leading in FMCG

Job Information

Regulatory Affairs

POSITION SUMMARY

 

Manage activities relating to product quality as well as quality management system on quality standards and compliance with local regulation.

MAJOR RESPONSIBILITIES

 1. To establish, revise and update accordingly all relating procedures in Quality Control / Quality Assurance base on Good Manufacturing Practices for Asean Cosmetic ( CGMP ), Policies and local regulations.

 

2. Ensure fully and strictly implementation of all processing and packaging/labelling standards, CGMP, MOH regulations and Microbiological Control Procedures.

 

3. Coordinate with Quality Assurance Department in foreign market where Vietnam import from/ to ensure that all products are complied with local regulatory and Asean Cosmetics Directives.

 

4. Provide the frequent support to production line in solving the concerned quality issues; suggest and follow-up the corrective actions and preventive actions in order to avoid the recurrence of the problems.

 

 

 

5. Investigate and determine non-conformity of finished ingredients, finished goods, incoming components based on Standards, raise Non-Merchandising Report ( NMR ), coordinate with Vietnam planning, export planning for settlement.

 

 

 

6. Coordinate with Customer Service to handle customer complaints on technical defects.

 

 

7. Ensure that all measured equipments in factory are properly calibrated and inspected.

 

 

8. Plan and lead internal audit at cross functions in the factory.

 

 

9. Product Notification & Product Information File (CFT & NCFT) to ensure being compliance with ACD and local regulations

 

 

10. Coordinate with appointed Third Party Inspection Agency ( TPIA ) – SGS, to control the product quality manufactured at local supplier / vendor.

.

 

11. Coordinate with Bureau Veritas ( assigned by Global ) to conduct Global Corporate Social Responsibility Program at the locally potential suppliers before placing business.

 

 

12. Review artworks done by Packaging Engineer and approved finally by Legal Manager during developing new products both CFT and NCFT.

 

13. Provide support technically in reviewing the R&D supportability of claims (against Claim sheet) and their acceptability against the ASEAN claim guidelines.

14. Provide technical support for government affairs initiative e.g. technical working group of local respective associations.

15. NCFT claims and IP issues by communicating feedback of NCFT quarterly safety & QA review particularly concerning acceptability of claims and IP status.

16. Work closely with local legal to assess impact and any legal concern of new regulations (CFT & NCFT) relating to business and to formulate strategy in handling the issue.

 

PROBLEM SOLVING AND DECISION MAKING

 

Materials usage variation exhibiting

Trouble shooting breakdown & determine the cause of breakdown.

Determine cost/benefit of equipment from an engineering point of view.

Productivity and Labour Standards

 

 

MAJOR EXTERNAL CONTACTS

 

CONTACT

NATURE

Regional RA

Legal

Sale

Marketing

HR

Production

Maintenance

Warehouse

Quatest 3

Institute of Drug Quality Control of HCMC /

Binh Duong Department of Health Third Party Manufacturer / SGS

Beurau Veritas

Binh Duong Department of Fire Fighting & Prevention

Holcim Vietnam

Binh Duong Department of Natural Resource and

Discuss and solve problems relating to quality and regulatory.

Filling and Packaging

Product quality, Traceability Maintenance and calibration schedule FPS, MSDS, Annual sampling and testing / Monitoring product quality of NCFT / Request and receive test report Training program on Fire Fighting and Prevention /

Plan and follow up disposal progress /

QUALIFICATIONS

Education University degree in Chemistry, Bách Khoa University

 

 

Experience Requirement

6 years experiences in quality control and quality assurance in multinational companies manufacturing cosmetics, pharmaceuticals.

 

Skills / Has acquired or developed the following skills.

Good spoken and written English skills.

Good communication and interpersonal skills across all levels of the organisation

Team working skills, flexibility, well-organised.

Good negotiating and influencing skills

Detailed understanding of the breadth of company administration work

Firm understanding of Vietnamese Labour Code and other related laws and regulations

Good computer skills and typing skills ( including Microsoft Office capability)

General Information

Ho Chi Minh

Comestic

Student

Media - Printing - Publishing Editor - Reporter - Writer

Negociate

Contact Us

Regulatory Affairs job closed

Mr. Nam Hoang

nam.hoang@headhuntvietnam.com

0907758782

Regulatory Affairs

Negociate

Ho Chi Minh

Comestic

Media - Printing - Publishing Editor - Reporter - Writer

Student

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