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QA Manager, Production

City: Beijing
Salary: 面议
Education: Bachelor
Experience: Eight Years
Job Nature: Full time

Job description:

    • Provide support, guidance and training to Research and Development and production teams.
    • Prepare, review and approve investigations, deviations, CAPA, change controls, batch record release, protocols, SOPs and any other reports as needed.
    • Assist with preparations for FDA Pre-Approval Inspection (PAI) and other compliance audits.
    • Develop goals and objectives for the QA department in alignment with the corporate goals and objectives.
    • Provide support, guidance and training to R&D/Production/QC teams.
    • Develop and manage internal quality system.
    • Oversee work performed by outside contractors to ensure meeting compliance.
    • Develop and execute an audit plan and coordinate the cGMP compliance audits.
    • Evaluate significance of audits findings and coordinate the findings responses with the contractors.
    • Participate in CMC meetings by presenting the regulatory compliance responsibilities and plans for sponsor audits of sites.
    • Review CMC documents including, but not limited to, protocols, amendments and reports for adequacy and compliance. 
    • Maintain current knowledge of cGMP/GLP regulations and company policy and procedures.
    • Participate as a liaison during relevant negotiations and/or inspections.
    • Write and review SOP for the Quality department.
    • Manage product complaint process.
    Job requirement:
    • Bachelor’s degree in Chemistry, Life Science, nursing or related field.
    • Minimum of 8 years of QA and auditing experiences in a cGMP/GLP/GCP/ pharmaceutical environment or equivalent with pharmaceutical sponsored clinical research, including PAI experiences.
    • Extensive knowledge of cGMP regulations, ICH guidelines for CMC.
    • Excellent communication, organizational, interpersonal and computer skills.
    • Ability to identify compliance issues, communicate issues to others and identify resolutions effectively.
    • Supervisory and management experience.
    • Knowledge of product recall is a plus.
    • Capable of communicating in English is a plus.
    • Willing to travel internationally.


    1469344803219 绿叶制药集团logo1
    Company Name: 绿叶制药集团
    address 山东省烟台市
    Company Industry: Pharmaceuticals/Biotechnology
    Company Nature: Private Enterprise
    Staff Size: 500+

    Welcome to join Luye to achieve your dream!

    Luye Pharma Group Co., a professional pharmaceutical enterprise listed on the main board of the Hong Kong Stock Exchange (02186.HK). We’re committed to providing high quality medical products and professional services to human health . And we’re committed to be the most respectful leading global pharmaceutical enterprise.If you are passionate about continuous innovation and overseas careers, here we can offer you a new brighter future.