QC Lab Manager - Manufacturing

GENERAL INFORMATION

§  Position: QC LAB MANAGER - MANUFACTURING

§  Job code: JO-170915-136428

§  Level: Manager

§  Contract term: Permanent

§  Recruitment reason: New-hired

§  Expected joining date: Pursuant to Vietnam Labor Law

§  Work location: Long Thanh, Dong Nai (company bus is provided from Bien Hoa and HCMC)

§  Work time:                    Monday - Friday (8:00am - 5:00pm)

Saturday (8:00am - 5:00pm, off twice per month)

JOB DUTIES

§  Report to Vietnamese Quality Manager

§  Team size: Around 50 Lab Staffs

§  Job Responsibilities:

-        Manage and provide leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives

-        Adequately participate in and support problem-solving needs of operating groups for all areas of the company and the development of new products

-        Communicate performance expectations as well as business and corporate policies to section staffs and others

-        Ensure accurate and complete associate records are maintained within the section

-        Develop and justify Corporate Capital Expenditure Requests (CER) and Corporate policies to support goals and mission objectives

-        Identify and lead departmental programs to improve productivity, quality, customer service, costs…

-        Work with management; develop 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

-        Develop 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

-        Monitor and interpret regulatory requirements in chemistry; develop strategies to assess residual EtO program and product compliance

-        Work with product line management to identify opportunities for optimization of the program(s); develop and maintain systems for tracking projects and continuous improvement activities

-        Actively work to identify new and expanding areas of contribution for the Toxicology Section

-        Others:

ü  Register and function as the Chief Microbiologist for the company with national and international regulatory groups including FDA, DOH and state agencies

ü  Responsible for all microbiological aspects of production and control necessary to ensure the sterility of all manufactured products

ü  Contribute as a member of the business regulatory compliance team; act as a member of the Institutional Animal Care and Use Committee and be responsible for maintaining compliance with all relevant requirements

ü  Review physical and equipment requirements for the laboratory; regularly assess short and long term needs and prioritizes equipment purchases

 

JOB REQUIREMENTS

§  Desirable Background and Experience:

-        Qualification: Bachelor Degree in related fields

-        Language skill(s): English fluent

-        Computing: MS Office proficiency

-        Minimum 5 years experience working at similar positions in foreign manufacturing companies (medical-related ones are preferable)

-        Demonstrated knowledge in:

ü  Applicable regulations affecting areas of responsibility

ü  Principal chemical, biological, physical, biochemical and/or environmental techniques as applicable to work assignments

ü  Applications and limitations of classical and instrumental chemical methods

ü  International regulations and requirements relevant to work assignments, GMP, IDE, PMA, 510(K), OSHA, EPA, DOT, and ISO

ü  FDA QSR/ISO 9000

-        Toxicology knowledge:

ü  GLP management and compliance with the Animal Welfare Act (IACUC)

ü  Developing programs subject to regulatory review and audit

ü  Cell biology, genotoxicity, and immunotoxicity

ü  Hematology and material biocompatibility beneficial

ü  ISO 10993 and related FDA G95-1 requirements including Physicochemical Materials Characterization

-        Proven ability in managing and developing staffs as well as building team-oriented atmosphere

-        Excellent oral presentation as well as effectively verbal and written communication skills

§  Desirable Characters:

-        Gender: Any

-        Age: Around 40-50s

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