QA Manager, Compliance

职位描述：

    • 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.
    职位要求：
    • 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.
    竞争福利
    绩效奖金, 通讯补贴, 年底双薪, 五险一金, 带薪年假, 定期体检, 节日福利
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    绿叶制药集团
    公司介绍
    Welcome to join Luye to achieve your dream！

    Luye Pharma Group Co., Ltd.is 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.

        绿叶制药集团是一家以研发为基础的专业制药企业，公司成立于1994年，2014年在香港主板上市(02186.HK)。公司在烟台、北京、南京、泸州和德国米斯巴赫设有生产基地，在中国、美国和欧洲设有研发中心，在香港、新加坡和马来西亚设有分支机构，全球员工近4000名。
        绿叶制药致力于创新药物的研发、生产和销售，30余个上市产品覆盖中枢神经系统、抗肿瘤、心血管、消化及代谢等规模最大及增长速度最快的治疗领域；业务遍及中国、美国、欧洲、澳洲、日韩等全球主要医药市场及新兴市场。绿叶制药建立了与国际接轨的研发体系，在微球、脂质体、透皮释药和皮下植入剂等新型给药系统领域处于国际先进水平。公司拥有丰富的在研产品线，多个创新制剂及创新药在美国FDA开展不同阶段的注册临床研究，并已取得突破性进展。
        绿叶制药将继续以创新和国际化为方向，力争成为最受尊敬的全球领先制药企业。

    使命：专业技术服务于人类健康
    愿景：成为最受尊敬的全球领先制药企业
    核心价值观：诚信、合作、创新、卓越

    公司以“成就员工”作为公司的经营理念，把员工视为绿叶最宝贵的财富：
    人力资源政策：采取积极主动的人力资源政策，吸引、保留海内外优秀人才
    多通道职业发展：建立多通道职业发展路径，充分发挥员工潜力，实现员工与公司的可持续发展
    绿叶常青学院：成立面向员工的企业内部大学——绿叶常青学院，培养后备管理人才
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