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quality control director.

职位概述

职位概览

    职位概述

    Responsibilities:

    1. Function management for product testing, including separation, biochemistry & in-process testing, leading testing group and project activities.
    2. To optimize the current QC analytics platform and develop new analytical capability and capacity to meet market demands.
    3. To work as a team with colleagues across various functions (at department, division, and company levels) in client service as well as capability buildup.
    4. To work as SME, solve technical challenges and support laboratory investigations.
    5. To oversee analytical method optimization, qualification/validation activities.
    6. To oversee audit preparation and response to the findings of clients and regulatory agencies.
    7. To work and drive continuous improvement of technical excellence, quality and efficiency of QC operation, ensuring the current quality systems in full compliance to all applicable regulatory standards, SOPs, GDP and safety standards.

     

    Requirements:

    1. M.S / Ph.D. in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, or related field.
    2. More than 10 years of relevant industrial experience.
    3. In-depth knowledge of FDA/EMA/CFDA cGMP regulations, Pharmacopoeias, and ICH guidelines and familiar with cutting-edge technologies.
    4. Demonstrated communication skills in both English and Chinese. Critical thinking, scientific reasoning and problem solving skills.
    5. Knowledge and expertise in some of the following fields: Biochemistry and immunochemistry techniques, such as ELISA, Immunoblot, SDS-PAGE, cell based bioassay, qPCR, etc.; Chromatographic and spectral techniques related to GC, HPLC, UPLC, GC, CE icIEF, IR and Raman, etc.; Compendial testing such as pH, osmolality, conductivity, Density, Refraction, Viscosity, Melting point etc.
    6. Capable of working with a large client base and a dynamic supporting team to deliver strong business growth.

    Responsibilities:

    1. Function management for product testing, including separation, biochemistry & in-process testing, leading testing group and project activities.
    2. To optimize the current QC analytics platform and develop new analytical capability and capacity to meet market demands.
    3. To work as a team with colleagues across various functions (at department, division, and company levels) in client service as well as capability buildup.
    4. To work as SME, solve technical challenges and support laboratory investigations.
    5. To oversee analytical method optimization, qualification/validation activities.
    6. To oversee audit preparation and response to the findings of clients and regulatory agencies.
    7. To work and drive continuous improvement of technical excellence, quality and efficiency of QC operation, ensuring the current quality systems in full compliance to all applicable regulatory standards, SOPs, GDP and safety standards.

     

    Requirements:

    1. M.S / Ph.D. in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, or related field.
    2. More than 10 years of relevant industrial experience.
    3. In-depth knowledge of FDA/EMA/CFDA cGMP regulations, Pharmacopoeias, and ICH guidelines and familiar with cutting-edge technologies.
    4. Demonstrated communication skills in both English and Chinese. Critical thinking, scientific reasoning and problem solving skills.
    5. Knowledge and expertise in some of the following fields: Biochemistry and immunochemistry techniques, such as ELISA, Immunoblot, SDS-PAGE, cell based bioassay, qPCR, etc.; Chromatographic and spectral techniques related to GC, HPLC, UPLC, GC, CE icIEF, IR and Raman, etc.; Compendial testing such as pH, osmolality, conductivity, Density, Refraction, Viscosity, Melting point etc.
    6. Capable of working with a large client base and a dynamic supporting team to deliver strong business growth.