长沙招聘

职位描述：
工厂规模：100人左右
需要英文流利（其中一个老板是老外）

1. 工 作 综 述 :
该职位向总经理汇报, 负责所有质量和EHS部门的管理, 包括人员, 计划, 指导, 预算以及日常工作以确保高质量的产品供应全球市场, 确保工厂GMP系统的执行和一致性, 符合全球所有市场的法规要求、EHS 要求和产品注册要求，符合ZQS和EHS的要求。参与所有与质量和EHS相关的事项, 负责生产过程中产品质量的控制。
? QA、 QC 实验室、验证和EHS部门的管理
? 管理公司文件系统, 培训系统和产品注册
? 质量和EHS问题处理
? 内、外部事务沟通
2. 工 作 职 责:

2.1 制定工厂QO部门的目标并确保与工厂的目标GQO的目标和全球EHS的目标保持一致；
2.2 通过精细化管理和持续改进的执行和应用确保运行效率不断提高；
2.3 确保部门费用使用的有效性，合理控制部门费用；
2.4 通过指导和与HR的协作保留和发展关键人员。促进团队合作和企业文化的建立；
2.5 确保部门员工的工作职责描述及其职责是充分体现本部门组织架构的，并在职责更改时及时更新；
2.5.1 QA、QC 、验证和EHS部门的管理
? 推动各项标准和规程的实施，确保产品质量和EHS目标；
? 审阅和批准所有与质量和EHS相关的文件, 包括SOP，测试方案，质量标准，测试方法，产品主文件，批记录，验证方案和报告；
? 确保原料和成品的及时放行/拒收；
? 进行年度产品质量审核；
? 制定GMP 自检计划，组织GMP自检；
? 制定年供应商审核计划。协助进行供应商审核，判断供应商是否符合要求；
? 组织接受GQCA或EHS方面的检查，内部自检和政府检查，确保发现的问题有行动计划和回复；
2.6.2 管理公司文件系统, 培训系统和产品注册
? 负责组织本部门人员的业务培训；协同人力资源组织并开展培训活动；
? 按市场注册要求及时提供注册文件和样品；
2.6.3 质量和EHS问题处理
? 协同, 审核和批准所有的更改控制，偏差调查, 确保关键偏差被调查和解决；
? 确保客户投诉被调查和解决，包括解答关于物理、化学及微生物测试方面的问题，及时提供投诉调查报告。处理退回产品；
2.6.4 外部事务沟通
? 负责处理好与质量或EHS方面的政府关系
? 为公司、客户和其它工厂提供有关统计和质量技术和EHS方面的咨询；
? 向客户和供应商提供关于质量方面的说明，以促进分销渠道中的质量提高；
? 领导产品转移项目和新产品QO部分的完成，如文件，测试方法和质量标准的转移，负责协助注册批的生产，开展稳定性试验和验证工作，准备和呈送注册文件给GMC；
? 负责新产品转化，提供测试方法，规范，组织实验性生产和稳定性试验，为农业部中监所提供批记录等；
3.　决策范围:
3.1. 员工管理:
3.1.1. QA 部门(6名)， QC部门(12名)，验证（2名）EHS（1名）
3.1.2. 全面负责部门人员管理。直接负责部门人员招聘，绩效评估，培训
3.2. 政策/程序: N/A

4.　基本要求:
4.1. 教育: 大学，化学，药学或微生物专业。有良好GMP知识。
4.2. 经历:
4.2.1. 至少5年药厂（最好是兽用生物制药相关企业）QA或QC 相关经验.
4.2.2. 良好的英语口语、书写能力，良好的计算机技能
4.3. 主要能力:
4.3.1. 管理能力
4.3.2. 计划和组织能力
4.3.3. 持续学习能力
4.3.4. 工作经历
4.3.5. 建立成功的团队
4.3.6. 问题解决能力
5. 任 职 条 件:
5.1. 大学，化学，药学或微生物专业。有良好GMP知识，良好的沟通和管理能力
5.2. 至少5年的药厂（最好是兽用生物制药相关企业）QA或QC相关工作经验。
5.3. 良好的英语口语、书写能力，良好的计算机技能



1. GENERAL DESCRIPTION:
Reporting to the General Manager, the focus of this position is to manage all quality operation functions and EHS that include staffing, planning, directing, budgeting and day to day operations to ensure the high quality of products distributed to customers. Make sure GMP is implemented and ensure GMP compliance. Meet regulatory requirements and products registration requirements for all markets. Implement Company’s Quality and EHS Systems. Involvement in all quality-related matters. Responsible for in-process quality control.
? Management routine affairs of QA QC Validation and EHS laboratory
? Management of documentation, training program and products registration
? Handling of any quality and EHS issues
? Internal and external communications on quality and EHS
2. DUTIES AND RESPONSIBILITIES:
2.1 Developing Site Quality Unit objectives consistent with Site objectives, Company’s Global Quality Operations objectives and Global EHS objectives.
2.2 To continuously improve through leading and initiating Right First Time and Risk Management activities accordingly.
2.3 To ensure the department operates cost effectively and the department expenses are controlled appropriately.
2.4 To ensure key talent maintained and developed through coaching and cooperation with HR. To promote teamwork and culture desired.
2.5 Management must ensure that colleague’s job descriptions and responsibilities adequately integrate with the internal control framework of the organization and updated in time once the related function changed.
2.5.1 Management of QA, QC Validation and EHS laboratory
? Lead the implementation of standards and procedures to ensure good quality and EHS
? Review and approve all appropriate quality-related and EHS-related documentation, including SOP, test protocol, specification, test method, batch document, validation protocol and report, etc.
? Release all raw material and all products in time.
? Performing annual product quality review.
? Make out GMP self-inspection plan. Make sure that self-inspections are performed.
? Make out supplier audit plan, and assist supplier audit, summarize all supplier information to decide if the supplier is approved.
? Organize receiving of Company’s Corporate Quality and EHS audit, internal audit, Regulatory inspection, etc. Assure action plan and responses are taken to findings of audit.
2.5.2 Management of documentation, training program and products registration
? Responsible for training within the department. Coordinates with HR to effectuate training.
? Provide legalized documents and samples for registration in time per market Regulatory Affairs requirements.
2.5.3 Handling of any quality and EHS issues
? Assists, Review and approve all change controls, deviations, investigations, make sure that critical deviation are investigated and resolved.
? Make sure that quality related complaints are investigated and resolved including giving answers on the aspects of physical, chemical and microbiological testing. Provide complaint investigation report in time. Returned goods handling.
2.5.4 External communications
? Manage relationships with the Ministry of Agriculture, Institute of Veterinary Drug Control, and other regulatory bodies in China that related to quality or EHS.
? Serves as a consultant for Company’s, customer and other Company’s division on statistics and quality issues.
? Keeps customers and suppliers informed of quality issues to enhance the quality of distribution channels.
? Lead completion of QO activities for product transfers and new products, including transfer of documentation, test methods, specifications etc. Organize registration batch manufacturing, stability study and validation. Prepare and submit dossiers to MOA/IVDC.
3. DECISION MAKING SCOPE:
3.1. Staffing:
3.1.1. QA department (~6 staff), QC department (~12 staff) EHS(~1 staff) Validation department (~2 staff)
3.1.2. Overall responsibility for all staff in function. Direct responsible for recruitment, performance review, coaching of staff in function.
3.2. Policy/Procedure: N/A

4. ESSENTIAL REQUIREMENTS:
4.1. Education:
At least college degree in microbiology, chemistry or pharmacy, and good knowledge of GMP.
4.2. Experience:
4.2.1. At least 5 years QA/QC related experience in pharmaceutical manufacturing, preferably in the manufacture of animal health vaccines.
4.2.2. Good oral, written English skill, good PC skill.
4.3. Core Competencies:
4.3.1. Management competency
4.3.2. Planning & Organizing
4.3.3. Continuous Learning
4.3.4. Work experience
4.3.5. Building a successful team
4.3.6. Problem solving

5. Qualifications:
5.1. At least college degree in microbiology, chemistry or pharmacy, good knowledge of GMP, good communication and management skills.
5.2. At least 5 years QA/QC related experience in pharmaceutical manufacturing.
5.3. Good oral, written English skill, good PC skill. 举报 分享

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