Laboratory Head - Medical Device - Nearby HCM - Welcome Expats Headhunt jobs

Laboratory Head - Medical Device - Nearby HCM - Welcome ExpatsHeadhunt jobs

Địa Điểm Làm Việc: Hồ Chí Minh | Bình Dương
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KPI Bonus
Health Insurance
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Mô Tả Công Việc

The qualified candidate will manage the laboratory team in performing product testing for product release and operations problem solving. Moreover, the Lab Head will establish and update the written procedures to ensure that product quality are controlled and aligned with polices, MoH regulatory, and FDA standards.


Description

The main roles and responsibilities are:

* Manage the laboratory team including: scientists, technicians, and operators in meeting organisational policies and processes and supporting.
* Short term and long term quality control planning and performance evaluation.
* Problem solving in research and development stage and operations quality control.
* Preparation and implementation of protocols and procedures.
* Develops policies in compliance with GMP, GLP principles follow US FDA and ISO requirements.
* Monitors and interprets regulatory requirements in Chemistry.
* Develops strategies to assess residual EtO program and product compliance.
* Actively works to identify new and expanding areas of contribution for the Toxicology
* Representing QA for final approval at Lab section
* Responsible for all microbiological aspects of production and quality control
* Coordinate with Regulatory Team.


Profile

The successful candidates are having:

* Pharmacist or, equivalent of education and working experience.
* Toxicology: A master's degree in Toxicology or related discipline, such as Hematology
* More than 3 years of experience in Laboratory Manager level in related industries such as medical devices, pharmaceuticals, or biology ....
* Effective leadership and manage people.
* Comprehensive knowledge of FDA, GMP, GLP, IDE, PMA, 510(K), OSHA, EPA, DOT, QSR/ ISO 13485 or ISO 9001, ISO 10993, FDA G95-1.
* Understanding of applications and limitations of classical and instrumental chemical.
* Experienced in developing programs for regulatory review.
* In-depth understanding in cell biology, genotoxicity, hematology and material biocompatibility
* Effective communication and cross-functional team collaborations.


Job Offer

Attract salary + international working environment + KPI bonus and other allowances and benefits


To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Tien Ong on +84 6284 8257
Xem toàn bộ Mô Tả Công Việc

Yêu Cầu Công Việc

The main roles and responsibilities are:

Manage the laboratory team including: scientists, technicians, and operators in meeting organisational policies and processes and supporting.
Short term and long term quality control planning and performance evaluation.
Problem solving in research and development stage and operations quality control.
Preparation and implementation of protocols and procedures.
Develops policies in compliance with GMP, GLP principles follow US FDA and ISO requirements.
Monitors and interprets regulatory requirements in Chemistry.
Develops strategies to assess residual EtO program and product compliance.
Actively works to identify new and expanding areas of contribution for the Toxicology
Representing QA for final approval at Lab section
Responsible for all microbiological aspects of production and quality control
Coordinate with Regulatory Team.

The successful candidates are having:

Pharmacist or, equivalent of education and working experience.
Toxicology: A master's degree in Toxicology or related discipline, such as Hematology
More than 3 years of experience in Laboratory Manager level in related industries such as medical devices, pharmaceuticals, or biology ....
Effective leadership and manage people.
Comprehensive knowledge of FDA, GMP, GLP, IDE, PMA, 510(K), OSHA, EPA, DOT, QSR/ ISO 13485 or ISO 9001, ISO 10993, FDA G95-1.
Understanding of applications and limitations of classical and instrumental chemical.
Experienced in developing programs for regulatory review.
In-depth understanding in cell biology, genotoxicity, hematology and material biocompatibility
Effective communication and cross-functional team collaborations.

Địa Điểm Làm Việc

Ho Chi Minh
Binh Duong

Our client is the leading international medical device manufacturing company with its factory located nearby Ho Chi Minh City. Expats are welcomed to apply for this positions. Transportation is provided.

Xem toàn bộ thông tin công ty
Ho Chi Minh
1.000-4.999 nhân viên
Tien Ong
CHƯƠNG TRÌNH TUYỂN SINH THẠC SĨ QUẢN TRỊ THƯƠNG MẠI QUỐC TẾ - ĐẠI HỌC CÔTE D’AZUR (PHÁP)

CHƯƠNG TRÌNH TUYỂN SINH THẠC SĨ QUẢN TRỊ THƯƠNG MẠI QUỐC TẾ - ĐẠI HỌC CÔTE D’AZUR (PHÁP)

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