KY NGUYEN VANG SERVICE TRADE CO.

, LTD
Address: Floor 6, Golden Bee Building
60A Hoang Van Thu St, W.5, Phu Nhuan Dist, HCMC
Tel: (+84 8) 3 9975721- 3 9976956
Fax: (+84 8) 39979719
Email: info@kynguyenvang.com
Website : www.dulieuvieclam.com

Invitation From Ky Nguyen Vang Consulting

JOB DESCRIPTION
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POSITION: QC LAB MANAGER

ESSENTIAL DUTIES
Manages and provides leadership for the functional groups development, direction, and effectiveness,
adhering to organizational policies and processes and supporting overall business and corporate objectives.
Adequately participates in and supports the problem-solving needs of operating groups for all areas of the
company and the development of new products.
Communicates performance expectations and business and corporate policies to section staff and others.
Ensures accurate and complete associate records are maintained within the section.
Develops and justifies Corporate Capital Expenditure Requests (CER) and Corporate policies to support goals
and mission objectives.
Identifies and leads departmental programs to improve productivity, quality, customer service, costs, etc.
Represents and presents the Company's position when interacting with representatives of regulatory
agencies.
Working with management, develops preliminary section budgets, goals, objectives, and operations that will
be integrated into the full department budget.
Responsible for the preparation and implementation of protocols and procedures involving known infectious
or potentially infectious agents.
Develops policies, programs, and strategies to ensure compliance with FDA and ISO requirements. This may
include compliance with relevant material and biocompatibility requirements for the company.
Monitors and interprets regulatory requirements in Chemistry. Generates position statements on specific
topics of Company interests.
Develops strategies to assess residual EtO program and product compliance. Works with product line
management to identify opportunities for optimization of the program(s).
Develops and maintains systems for tracking projects and continuous improvement activities.
Actively works to identify new and expanding areas of contribution for the Toxicology Section.

OTHER DUTIES AND RESPONSIBILITIES

May register and function as the Chief Microbiologist for the company with national and international
regulatory groups including the FDA, the DOH, and state agencies. Will be responsible for all microbiological
aspects of production and control necessary to ensure the sterility of all manufactured products.
May contribute as a member of the business regulatory compliance team.
Reviews physical and equipment requirements for the laboratory. Regularly assesses short and long term
needs and prioritizes equipment purchases.
May act as a member of the Institutional Animal Care and Use Committee and is responsible for maintaining
compliance with all relevant requirements.
.

MINIMUM QUALIFICATION REQUIREMENTS

Education
Bachelors degree or, equivalent of education and experience sufficient to successfully perform the essential functions
of the job may be considered.
Toxicology: A masters degree in Toxicology or related discipline, such as Hematology, is preferred.

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 KY NGUYEN VANG SERVICE TRADE CO., LTD
Address: Floor 6, Golden Bee Building
60A Hoang Van Thu St, W.5, Phu Nhuan Dist, HCMC
Tel: (+84 8) 3 9975721- 3 9976956
Fax: (+84 8) 39979719
Email: info@kynguyenvang.com
Website : www.dulieuvieclam.com

Invitation From Ky Nguyen Vang Consulting

Experience
Minimum 5 years experience
The fully performing individual will possess five or more years of supervisory experience with eight years of
graduate study or industry experience.

Skills
Demonstrated and effective leadership and managerial skills.
Demonstrated knowledge in applicable regulations affecting areas of responsibility.
Comprehensive knowledge of the principal chemical, biological, physical, biochemical, and/or environmental
techniques as applicable to work assignments.
Comprehensive knowledge of FDA and international regulations and requirements relevant to work
assignments, GMP, IDE, PMA, 510(K), OSHA, EPA, DOT, and ISO.
Ability to select, develop, and evaluate staff.
Ability to succeed in a team oriented atmosphere and lead team activities.
Excellent oral presentation skills.
Comprehensive knowledge of FDA QSR/ISO 9000.
Understanding of applications and limitations of classical and instrumental chemical methods.
Toxicology: Experienced in GLP management and compliance with the Animal Welfare Act (IACUC).
Toxicology: Experienced in developing programs subject to regulatory review and audit.
Toxicology: Experienced in cell biology, genotoxicity, and immunotoxicity.
Toxicology: Experienced in hematology and material biocompatibility beneficial.
Toxicology: Comprehensive knowledge of ISO 10993 and related FDA G95-1 requirements including
Physicochemical Materials Characterization.
Knowledge and use of relevant PC software applications and skills to use them effectively.
Demonstrated ability to communicate effectively both verbally and in writing.

Thng tin lin h thm:

- Mr. Nam
- Phone: 0927 507 323
- Mail: hrconsultant_16@kynguyenvang.com or kynguyenvang.ac02@gmail.com

You are a best candidate!

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