Site QA Manager
帝斯曼(中国)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2016-12-29
- 工作地点:无锡-宜兴市
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:1500以下/月
- 职位类别:质量管理/测试经理(QA/QC经理)
职位描述
职位描述:
Job Title: Site QA Manager
Reports to: BU Global QA Manager, Site Manager
Responsibilities:
1. Make assure the quality system agreed in the company is implemented.
2. To assure the products are produced according to the requirements of Quality management system
3. Running Quality system with FSSC 22000, HACCP and Basic GMP requirement.
4. SHE
- To be responsible for Safety, Health and Environment within QUALITY ASSURANCE AND Quality control and promote/contribute to safe working practices at all times.
- He/she observes the Legal and SHE requirements and initiates immediate actions when requirements are not met or when a dangerous situation occurs.
- To ensure adequate reporting of all accidents and incidents in accordance with DSM requirements.
5. QA/QC
- Ensure to have the appropriate systems (e.g. Quality & Food Safety Management System, cGMP) in place and maintained, in line with all applicable laws, regulations and standards.
- Approve and release the end product, raw materials and intermediate.
- Preside over the revision of the specifications of end product, raw materials and intermediate.
- Be responsible to execute the stability study plan and evaluate the results.
- Stipulate for the sampling plan and remaining sample stipulation
- Be responsible to work out the conclusion of investigation of disapproval product.
- Check and approve all of the documents which concerning the quality, including quality policy, SOP, master production instruction, batch record.
- Prepare and implement the annual audit plan. Execute and follow up on internal and external quality audits, in order to ensure that activities are carried out according to approved policies and procedures.
- Be responsible to receive and accompany the governmental and customer audit.
- Be responsible to treat with the customer complaint.
- Approve the deviation investigation report and correction plan. Ensure that the organization learns from deviations and escalate to the appropriate management level, if and where required.
- With responsibility for the performance review of QC employees
- Prepare job description for underling (or let them prepare), Motivate and coached people and take care for a good atmosphere in the department.
- Manage Quality Control Department including method transfers and analysis.
- Monitor the execution of the quality & food safety plan and take corrective actions, in order to achieve the results.
- Periodically review the quality & food safety system and verify whether these are actual.
- Define in consultation with the regional QA manager and implement performance indicators and unsure periodical reporting of actual performance against these indicators. Ensure that site director is kept informed of quality performance on the site.
- Define conditions under which a derogation to established specifications, standards and procedures may be implemented and be responsible for tis approval
- Secure that the “Management of Change Manufacturing” process properly identifies and mitigates any quality-related risk triggered by the change
- Set up and maintain the relevant network with external stakeholders and represent the site towards external parties on quality topics and issues
- Pro-actively identify potential quality and compliance risks
- Strengthen the QA capabilities of your team. Lead and coach together with regional /BU QA manager, the site QA team members on critical quality issues that could impact on product quality and/or safety
- Drive a continuous Quality and Compliance Improvement mind-set within the organization
- Always secure that the priority setting implemented within your team activates matches with the strategy and the ambitions of the organization
6. Authorities
- It will be entitled to advice for a temporary production stop if there is serious unclear deviation.
- It will be entitled to reject the batch production record/batch analytical record and release products when the investigation of critical deviation is not finished.
- Advise for the rewarding, punishment, and transfer of QA/QC employees
- Arranging holidays & Delegate authorities
- Increase employees according to task necessary.
7. Projects/special assignments
- Support/challenge the Ready to Operate process for the site of DJB.
- Support investment projects in DJB.
The Ideal
1. Bachelor degree and above, Chemical Technology/Engineering and biochemical tech/engineering or food industry/engineering preferred.
2. Over 5 years experiences in in the field of quality management, prefer in biotech or chemical industries.
3. Have some experiences on production in food and/or fermentation industries
4. Know well the quality management such as ISO and HACCP and GMP.
5. Good communication and social skills
6. Good oral & written English
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Job Title: Site QA Manager
Reports to: BU Global QA Manager, Site Manager
Responsibilities:
1. Make assure the quality system agreed in the company is implemented.
2. To assure the products are produced according to the requirements of Quality management system
3. Running Quality system with FSSC 22000, HACCP and Basic GMP requirement.
4. SHE
- To be responsible for Safety, Health and Environment within QUALITY ASSURANCE AND Quality control and promote/contribute to safe working practices at all times.
- He/she observes the Legal and SHE requirements and initiates immediate actions when requirements are not met or when a dangerous situation occurs.
- To ensure adequate reporting of all accidents and incidents in accordance with DSM requirements.
5. QA/QC
- Ensure to have the appropriate systems (e.g. Quality & Food Safety Management System, cGMP) in place and maintained, in line with all applicable laws, regulations and standards.
- Approve and release the end product, raw materials and intermediate.
- Preside over the revision of the specifications of end product, raw materials and intermediate.
- Be responsible to execute the stability study plan and evaluate the results.
- Stipulate for the sampling plan and remaining sample stipulation
- Be responsible to work out the conclusion of investigation of disapproval product.
- Check and approve all of the documents which concerning the quality, including quality policy, SOP, master production instruction, batch record.
- Prepare and implement the annual audit plan. Execute and follow up on internal and external quality audits, in order to ensure that activities are carried out according to approved policies and procedures.
- Be responsible to receive and accompany the governmental and customer audit.
- Be responsible to treat with the customer complaint.
- Approve the deviation investigation report and correction plan. Ensure that the organization learns from deviations and escalate to the appropriate management level, if and where required.
- With responsibility for the performance review of QC employees
- Prepare job description for underling (or let them prepare), Motivate and coached people and take care for a good atmosphere in the department.
- Manage Quality Control Department including method transfers and analysis.
- Monitor the execution of the quality & food safety plan and take corrective actions, in order to achieve the results.
- Periodically review the quality & food safety system and verify whether these are actual.
- Define in consultation with the regional QA manager and implement performance indicators and unsure periodical reporting of actual performance against these indicators. Ensure that site director is kept informed of quality performance on the site.
- Define conditions under which a derogation to established specifications, standards and procedures may be implemented and be responsible for tis approval
- Secure that the “Management of Change Manufacturing” process properly identifies and mitigates any quality-related risk triggered by the change
- Set up and maintain the relevant network with external stakeholders and represent the site towards external parties on quality topics and issues
- Pro-actively identify potential quality and compliance risks
- Strengthen the QA capabilities of your team. Lead and coach together with regional /BU QA manager, the site QA team members on critical quality issues that could impact on product quality and/or safety
- Drive a continuous Quality and Compliance Improvement mind-set within the organization
- Always secure that the priority setting implemented within your team activates matches with the strategy and the ambitions of the organization
6. Authorities
- It will be entitled to advice for a temporary production stop if there is serious unclear deviation.
- It will be entitled to reject the batch production record/batch analytical record and release products when the investigation of critical deviation is not finished.
- Advise for the rewarding, punishment, and transfer of QA/QC employees
- Arranging holidays & Delegate authorities
- Increase employees according to task necessary.
7. Projects/special assignments
- Support/challenge the Ready to Operate process for the site of DJB.
- Support investment projects in DJB.
The Ideal
1. Bachelor degree and above, Chemical Technology/Engineering and biochemical tech/engineering or food industry/engineering preferred.
2. Over 5 years experiences in in the field of quality management, prefer in biotech or chemical industries.
3. Have some experiences on production in food and/or fermentation industries
4. Know well the quality management such as ISO and HACCP and GMP.
5. Good communication and social skills
6. Good oral & written English
职能类别: 质量管理/测试经理(QA/QC经理)
公司介绍
公司简介(中):
帝斯曼在中国
荷兰皇家帝斯曼集团是一家以目标为导向,在全球范围内活跃于营养、健康和绿色生活的全球科学公司。帝斯曼不断推动经济繁荣、环境改善和社会进步,为所有利益相关方创造可持续的价值。帝斯曼为包括人类营养、动物营养、个人护理与香原料、医疗设备、绿色产品与应用以及新型移动性与连接性领域提供创新业务解决方案。帝斯曼及其关联公司约 23,000 名员工创造了约 100 亿欧元的年度净销售额。公司已在泛欧阿姆斯特丹交易所上市 (Euronext Amsterdam)。
帝斯曼早在1963年开始对华贸易,十几年前开始在华投资。帝斯曼中国地区总部和研发中心位于上海,目前在中国拥有共14个生产场地, 员工约3,000名。帝斯曼在中国业务正稳步增长,2009年在中国销售额约12亿美元。同时,帝斯曼也正一如既往地全方位融入中国的可持续发展事业。
欲了解更多信息,请访问:**************
Bright Science. Brighter Living.
Royal DSM is a purpose-led global science-based company in Nutrition, Health and Sustainable Living. DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative business solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about 10 billion with approximately 23,000 employees. The company is listed on Euronext Amsterdam.
DSM began trading with China in 1963 and established its first China sales office and first manufacturing facility in early 1990s. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. The company currently has 40 affiliates in China including 26 manufacturing sites and employs about 3,500 people. DSM China regional headquarters and China Science and Technology Center are located in Shanghai.
DSM’s business is growing healthily and steadily in China with revenue of USD1.7 billion in 2012. In line with DSM’s global vision, we advocate sustainability via the partnering with a high growth economy while internally we embrace diversity and localization of management to empower local talent. We strive to be an Employer of Choice and take pride in attracting, developing and retaining talent by enhancing a forward thinking working environment with a high-performance culture encouraging collaborative action.
Are you ready for a Bright and Positive journey with us? Please visit our website and check out the career opportunities with DSM China.
帝斯曼在中国
荷兰皇家帝斯曼集团是一家以目标为导向,在全球范围内活跃于营养、健康和绿色生活的全球科学公司。帝斯曼不断推动经济繁荣、环境改善和社会进步,为所有利益相关方创造可持续的价值。帝斯曼为包括人类营养、动物营养、个人护理与香原料、医疗设备、绿色产品与应用以及新型移动性与连接性领域提供创新业务解决方案。帝斯曼及其关联公司约 23,000 名员工创造了约 100 亿欧元的年度净销售额。公司已在泛欧阿姆斯特丹交易所上市 (Euronext Amsterdam)。
帝斯曼早在1963年开始对华贸易,十几年前开始在华投资。帝斯曼中国地区总部和研发中心位于上海,目前在中国拥有共14个生产场地, 员工约3,000名。帝斯曼在中国业务正稳步增长,2009年在中国销售额约12亿美元。同时,帝斯曼也正一如既往地全方位融入中国的可持续发展事业。
欲了解更多信息,请访问:**************
Bright Science. Brighter Living.
Royal DSM is a purpose-led global science-based company in Nutrition, Health and Sustainable Living. DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative business solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about 10 billion with approximately 23,000 employees. The company is listed on Euronext Amsterdam.
DSM began trading with China in 1963 and established its first China sales office and first manufacturing facility in early 1990s. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. The company currently has 40 affiliates in China including 26 manufacturing sites and employs about 3,500 people. DSM China regional headquarters and China Science and Technology Center are located in Shanghai.
DSM’s business is growing healthily and steadily in China with revenue of USD1.7 billion in 2012. In line with DSM’s global vision, we advocate sustainability via the partnering with a high growth economy while internally we embrace diversity and localization of management to empower local talent. We strive to be an Employer of Choice and take pride in attracting, developing and retaining talent by enhancing a forward thinking working environment with a high-performance culture encouraging collaborative action.
Are you ready for a Bright and Positive journey with us? Please visit our website and check out the career opportunities with DSM China.
联系方式
- Email:Irene-IW.Wang@dsm.com
- 公司地址:浦东新区李冰路476号