职位名称Position
Title：生产主管Production Supervisor

主要工作职责： 协助生产经理负责工厂的所有生产活动，制定和执行生产计划和程序, 确保在预期的产量、质量及成本的基础上有效地运用人力、物力及设备，优化生产率，达成生产目标，并确保生产活动符合公司短期和长期发展目标，符合相关健康、安全、环保和质量标准；管理并培训员工。

Main responsibilities：Assist production
manager to be responsible for all the production activities, develop and
implement manufacturing plan and procedures, allocate labor, material resource
and equipment to ensure achievements of production objectives and keep
optimizing productivity; ensure all production activities to meet short and
long-term business objectives of the plant, and are conducted in accordance
with GMP/CSR/EHS standards；manage and train
subordinates.

Ø 具体如下：Details are as following：

1. 管理和组织生产活动

Production activities management work

ü
制定、确定、修订生产计划,并保证生产计划的有效执行，最大限度满足销售要求；

Proceed, review, confirm and follow-up the manufacturing plan to satisfy the
market requirement maximally；

ü
根据生产计划组织生产活动，并确保全部生产过程的运行符合GMP的要求和达到 ISO质量管理体系的标准,产品质量符合质量标准；

Organize manufacturing activities according to the production plan, monitor the
total process and ensure that they are in accordance with the requirement of
GMP and ISO Quality Assurance System；

ü
熟悉造粒、压片、包衣、包装等相关的生产操作及相关区域的规程；

Have good knowledge about granulation, tablet compression, film-coating,
package operation and relevant area regulations；

ü
制定生产工艺，系统地回顾并证明其可持续稳定地生产出符合要求的产品；

Develop production processes, systems and prove its review of the sustainable
and stable production of products to meet the requirements；

ü
制订中间产品的质量标准；

Develop quality standards of intermediate product;

ü
负责生产清场开批、结批和安排各种模具的更换，最大限度地保证产量；

Be responsible for the line clearance,
batch start, the batch end and model change to
maximize the productivity；

ü 起草和回顾生产相关文件,包括批记录,工艺规程,设备操作等的标准操作程序;

Draft and review the related production documents including product batch
record, standard procedure and SOPs；

ü 审核和批准产品的工艺规程、操作规程等文件；

Review and approve products technical rules, procedures and other documents

ü 批准并监督委托生产；

Approval and supervision of contract manufacturing;

ü
及时向经理汇报并负责处理生产过程中的异常;负责事件和偏差的处理和改进工作

Notify the unordinary issues to the Manager in
time, in charge of the disposition and improvement concerning the event and
deviation;

ü
参与生产运行过程的风险评估，产品回顾和生产工艺的维护工作;

Involve in the risk assessment, product review and production process
maintenance in the production processing;

ü
协助评估并改进生产方法、设计、设备与技术；

Assist evaluation and develop production method, design, equipment and
technique；

ü
对生产过程中的偏差进行分析，并提出纠正和预防措施；

Analyze the deviation in the process of manufacturing, conduct the correct
action and precaution measurement；

ü 掌握设备运行状况, 通过实时监控,控制生产过程,并对设备设施进行必要的维护监督和提出维修和改进建议，以满足产品生产和产品质量的要求；

Keep the equipments in running status,
monitor the whole manufacturing process automatically, and implement maintains
and repair work in advance if necessary to meet the requirements of product
manufacture and quality；

ü 确保员工资源及其经验可适应生产计划的完成；

Ensure there are adequate human resources with appropriate experience for the
achievement of the manufacturing plan；

ü
激励员工的创新思维,不断改进质量、降低成本、提高生产效率；

Inspire with the people for their awareness of innovation to develop quality,
decrease cost and improve the production efficiency；

2. 检查和监督工作 check and monitor work

ü
监督生产过程中各项操作的准确性和正确性，确保药品按照批准的工艺规程生产、贮存，以保证药品质量,符合SOP和有关规定要求；

Monitor the precious and accuracy of every operation in the whole manufacturing
processes to be sure that it meet the requirements of approved technical rules,
the drug production and storage, to ensure drug quality and in accordance with
SOPs and relevant regulations；

ü
确定和监控物料和产品的贮存条件；

Identification and monitoring of materials and product storage conditions;

ü
监督和检查记录的填写，保证其正确性和真实性；确保批生产记录和批包装记录经过指定人员审核并送交质量管理部门；

Monitor and check the records to be sure that records are correctly and truly；ensure that the batch records and batch packaging
record had been reviewed by the specified person and hand them over to quality department;

ü
确保严格执行与生产操作相关的各种操作规程；

Ensure the strict implementation of various production operation related
procedures;

ü
确保厂房和设备的维护保养，以保持其良好的运行状态；

Ensure plant and equipment maintenance to keep it in good working condition;

ü
监督各机器设备的清洁，确保其卫生状况符合GMP规范；

Monitor the clean status of equipments to make sure that it meets the
requirement of GMP regulations；

ü
监督生产区域的洁净，防止交叉污染，监督对生产用的设备和容器予以正确的状态标识；

Supervise the clean and prevent cross-contamination in the production area and
monitor correctly label on the equipment and containers used in production；

ü
监督各区域、房间卫生状况符合GMP规范；

Monitor the sanitation status of each production area and room to make sure
that they meet the requirement of GMP regulations；

ü
监督各岗位设备标识、产品标记、原辅料标识及包装材料标识的准确性;

Monitor the veracity of all kinds of status label such as equipment label,
product label, raw materials label and package materials label;

ü
监控影响产品质量的因素;

Monitor the factors that affect product quality;

ü
监督GMP执行状况；

Monitor the status of implementation of GMP

3. 验证工作

Validation

ü
负责生产设备,生产工艺验证方案的起草；

Responsible for preparing validation protocol of production equipments and
manufacturing process；

ü
按照验证计划实施验证工作,确保完成各种必要的验证工作；

In charge of implementation of validation according to the protocol, ensure the
completion of the necessary validations;

4. 培训工作

Training

ü
负责生产相关文件的培训；

In charge of training operators of related production documents；

ü
确保生产相关人员经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容;

Ensure the necessary pre-service training and continuing training to the
relevant persons, and training need to be adjusted according to actual content.

5. 统计工作

Statistic work

ü
对生产和包装的产量和消耗进行统计；

In charge of statistic turnout and cost including manufacturing and packaging；

ü
对设备的停机情况进行分析，提出改进建议。

In charge of analysis downtime of equipment and propose improvement.

6. 生产经理不在的时候，代理行使经理的职责与权力

Deputy of department manager duties and power in case of production manager
absence.

7. 环境、安全、健康及质量：遵守GMP及所有EHS规定，并督导员工遵照执行；

Environment, Health, Safety & Quality: to observe all GMP, EHS
requirements, emphasise these standards/norms to employees and request that
they adhere to them;

8. 完成生产效率和绩效提高的相应项目

Complete assigned projects/tasks based on site & dept. performance leader’s
arrangement.

Ø 基本要求 Basic Requirements

1. 38岁以下，形象端正，身体无过敏情况；

Under 38 years old, with good image and no history
of allergy；

2. 大学本科以上学历，药学或相关专业，具有中级专业技术职称或执业药师资格

Should at least have the bachelor’s degree or above,
major in pharmacy or related (Intermediate professional titles or Licensed
Pharmacist),

3. 五年以上外资制药企业生产/工艺相关工作经验，两年以上从事药品生产和质量管理的工作经验，其中至少有一年的药品生产管理经验，接受过与所生产产品相关的专业知识培训;

More than 5 years working experience in
pharmaceutical production/process in FIE pharma. At least two years’ experience
in the pharmaceutical manufacturing and quality management, including at least
one year experience in pharmaceutical production management, received with the
production of product-related knowledge and skill training;

4. 熟悉固体制剂GMP规范，SOP或工艺设备；

Familiar with solid preparations of GMP, SOP and
process equipment;

5. CET4以上且能熟练使用英语作为工作语言；

CET4 or above and good command of English as
working language;

素质要求 Qualifications

Ø 强烈的工作责任心和敬业精神；

Commitment to success and accountability；

Ø 良好的组织和管理能力；

Good organization and management ability；

Ø 良好的沟通技巧和协调能力；

Good communication skill and coordinative ability；

Ø 具有督导和培训下属的管理经验；耐心、细致的工作态度；

Having practical experiments of supervising and training subordinates; Patience
needed and care for people；

Ø 为人诚实、正直、对事物具有正确的判断力和解决能力；

Honest and integrity, good at problem solving；

Ø 能在压力下保持高效率的工作；

Ability of keeping high efficiency on work under high pressure；

Ø 具有良好的团队合作精神

Team Work Spirit

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