1.Responsible  for the operation of equipment during manufacturing activities, Vial  washing machine, manual inspection and consumables inventory.

负责在生产活动期间设备的操作，小瓶清洗机、人工检查和耗材库存。

2.Responsible for the personnel activities working in this area.

负责在此区域内工作人员的活动。

3.Provide technical mentorship to Manufacturing staff.

为生产员工提供技术指导。

4.Preparation, Review and implementation of SOPs and protocols for the process

起草、审核、实施工艺的标准操作规程和方案。

5.Participate in all the operations including parts change over when required

需要时，参与所有的运营活动，包括部件更换。

6.Responsible for planning areas activities to keep high production productivity

负责计划区域内的活动以保持高生产率。

7.Support engineering department with relevant data for improving equipment efficiency and productivity.

为工程部提供用于提高设备效率和生产率的相关数据。

8.Assist management during investigation reports.

在调查报告期间协助管理工作。

9.When required participate in the Operations Organization Meeting.

需要时，参与运营组织会议。

10.Responsible  to ensure the cleaning, sanitization and or decontamination of the  cleanroom areas and equipment are performed and properly documented

负责确保已执行洁净区和设备的清洁、消毒或去污工作，并已进行恰当记录。

11.Responsible for ensuring the setup of the equipment / format parts are performed in accordance with the batch records.

负责确保按照批记录对设备/模具进行设置。

12.Undertake aseptic simulations during the manufacturing activities process according to procedures.

按照规程在生产活动流程中进行无菌模拟。

13.Undertake line clearance of the operation areas / room spaces.

在操作区域/房间区域内进行生产线清场。

14.Responsible Completion of the batch records and associated documents during manufacturing.

负责在生产期间完成批记录和相关文件。

15.Support the routine preventative maintenance of the equipment.

为设备的日常预防性维护提供支持。

16.Support the non-routine maintenance of the equipment.

为设备的非日常维护提供支持。

17.Support filling equipment qualification, validation and revalidation

为灌装设备的确认、验证和再验证提供支持。

牡丹江基纳瑞克斯生物制药有限公司位于黑龙江省牡丹江海林市经济开发区内。总投资额5亿元，注册资金3千万美元。占地面积44000平方米。建筑总面积15000平方米。共分为生产区、行政办公区及配套服务区等。生产全部采用当今世界最先进的工艺，设备全部自德国、意大利等国家直接进口。企业建成后将填补黑龙江省专业抗肿瘤药物生产领域空白