FDA specialist manager
FOREO
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：贸易/进出口 快速消费品(食品、饮料、化妆品)
职位信息
- 发布日期：2013-12-17
- 工作地点：苏州-工业园区
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：质量管理/测试经理(QA/QC经理) 食品/饮料研发
职位描述
You can challenge yourself with the exciting task of creating a Quality Unit surpassing current industry standards.
? Responsible for documentation, procedures, standards and upgrading the QA Management system; with shared responsibility for managing the ISO 9000 certification and GMP coaching across all plants (continuous bulk production)
? Resident expert for Q7A and QA for products used in feed, food, and API
? Primary contact for regulatory agencies
? Manage two direct reports; a customer complaint coordinator and a QA team member
?If this challenging role is right for you, apply now to be considered.
Responsibilities
? Manages the Green River quality management systems; ensuring they meet internal and external customer expectations.
? Ensures compliance with product safety regulatory requirements including approval of quality and food safety related change management
? Ensures product claims and specifications are up-to-date and in accordance with applicable regulations and customer requirements.
? Ensure quality incidents are properly reported and investigated.
? Drive continuous quality improvement initiatives at the Green River site.
? Participate in new process development or major modification efforts (for new or modified products) to determine the impact upon quality.
? Management representative for the ISO 9000 system
? People development and performance management of direct reports
? Main interface with the Law/Communications Departments for communications on the website and to customers relating to Product compliances.
? Manage Improvements and Changes in Product related Regulatory Compliance
? Ensure that all quality action items are completed in a timely manner whether arising from follow-up to a quality incident, a customer quality audit, an internal or external ISO audit, an internal quality process improvement process, or other source.
? Lead site ISO 9001 maintenance and re-certification efforts
? Reply to customer questionnaires relating to the business
? Train production areas to ensure compliance with all Product related certifications
? Support Responsible Care program
? Develop and administer salary plan for direct reports
? Ensure that employees within area develop skills and capabilities to meet the needs of the business
? Provide necessary support and resources to the ISO 9000 system
? FDA/Food Safety Expert
? Leader of the Food Safety Team
? Quality Unit sign off on all Hemo and USP shipments
? Coordinate Mock Recalls
? ? Approve Quality portion of the Supply Chain’s Distribution and Transloading systems
? Provide training on Q7A cGMP for Alkali Chemicals Division
? Forward looking into the Q7A CGMP changes
? Forward looking into the USP changes
? Lead internal audits for the FDA and other product related certifications.
? Key participant in the FDA audits/visits
? Manage compliance with applicable regulatory and company standards, regulations and policies
? Maintain and expand knowledge product regulations especially in FDA and USP areas.
Qualifications
- IF a degree is required, you MUST include degree level ?(BS, MS, PhD)? and major?(s)?:
Required
?
? Minimum 5 years’ experience managing QA for bulk pharmaceutical excipient, manufacturing; 10 years preferred
? Minimum 5 years supervisory experience
Preferred
? Bulk continuous process manufacturing experience
? Q7A
? Kosher
? Hallal
? AWWA
? API
? NSF
? Feed grade
? Responsible for documentation, procedures, standards and upgrading the QA Management system; with shared responsibility for managing the ISO 9000 certification and GMP coaching across all plants (continuous bulk production)
? Resident expert for Q7A and QA for products used in feed, food, and API
? Primary contact for regulatory agencies
? Manage two direct reports; a customer complaint coordinator and a QA team member
?If this challenging role is right for you, apply now to be considered.
Responsibilities
? Manages the Green River quality management systems; ensuring they meet internal and external customer expectations.
? Ensures compliance with product safety regulatory requirements including approval of quality and food safety related change management
? Ensures product claims and specifications are up-to-date and in accordance with applicable regulations and customer requirements.
? Ensure quality incidents are properly reported and investigated.
? Drive continuous quality improvement initiatives at the Green River site.
? Participate in new process development or major modification efforts (for new or modified products) to determine the impact upon quality.
? Management representative for the ISO 9000 system
? People development and performance management of direct reports
? Main interface with the Law/Communications Departments for communications on the website and to customers relating to Product compliances.
? Manage Improvements and Changes in Product related Regulatory Compliance
? Ensure that all quality action items are completed in a timely manner whether arising from follow-up to a quality incident, a customer quality audit, an internal or external ISO audit, an internal quality process improvement process, or other source.
? Lead site ISO 9001 maintenance and re-certification efforts
? Reply to customer questionnaires relating to the business
? Train production areas to ensure compliance with all Product related certifications
? Support Responsible Care program
? Develop and administer salary plan for direct reports
? Ensure that employees within area develop skills and capabilities to meet the needs of the business
? Provide necessary support and resources to the ISO 9000 system
? FDA/Food Safety Expert
? Leader of the Food Safety Team
? Quality Unit sign off on all Hemo and USP shipments
? Coordinate Mock Recalls
? ? Approve Quality portion of the Supply Chain’s Distribution and Transloading systems
? Provide training on Q7A cGMP for Alkali Chemicals Division
? Forward looking into the Q7A CGMP changes
? Forward looking into the USP changes
? Lead internal audits for the FDA and other product related certifications.
? Key participant in the FDA audits/visits
? Manage compliance with applicable regulatory and company standards, regulations and policies
? Maintain and expand knowledge product regulations especially in FDA and USP areas.
Qualifications
- IF a degree is required, you MUST include degree level ?(BS, MS, PhD)? and major?(s)?:
Required
?
? Minimum 5 years’ experience managing QA for bulk pharmaceutical excipient, manufacturing; 10 years preferred
? Minimum 5 years supervisory experience
Preferred
? Bulk continuous process manufacturing experience
? Q7A
? Kosher
? Hallal
? AWWA
? API
? NSF
? Feed grade
公司介绍
About FOREO
FOREO’s significance surpasses the cosmetic – by treating the body as a living, breathing whole, caring for the skin becomes a new style of living that promotes confidence and total well-being. With unprecedented solutions that map the future of sustainable, long-term skincare, our challenge to the beauty and wellness industry is global in scale.
This new approach is centered on radical innovations that bring tangible, lasting enhancements to the health of the skin. Without resorting to smoke and mirrors, we explain and illustrate the benefits of our products clearly, because they work precisely as effectively as we claim. Informed by the latest dermatological and cosmetic research, in collaboration with the most qualified professionals, we adopt a results-oriented approach that sets us apart from our competitors.
Groundbreaking technology, immaculate service, and the credibility that flows from communication of genuine substance will all help us to win the loyalty of our customers. Yet ultimately it will be the superiority of our products that will make FOREO the first name on people’s minds when discussing the potential for beautiful skin.
关于斐珞尔
BEAYTY BEYOND COSMETICS 不仅仅是化妆品
FOREO是一家设计、生产和销售护肤仪器的瑞典公司。FOREO产品系列于2013年在中国正式启动，经过10多年的研究和发展，依靠皮肤科医生、细胞生物学家、美学家和机械工程师的专业知识，为各方面的护肤和健康需求提供高品质有效的解决方案。
首次推出的LUNA抗衰老和面部清洁刷系列，FOREO的定位就是在保证产品质量卓越的基础上给人们的生活带来难以想象的改善。通过遍布美国，欧洲和亚洲的完善的销售渠道，我们很高兴与全球客户分享我们革命性的护肤方法。
FOREO系列的问世对美容行业具有里程碑式的意义 ，因为我们把身体看做一个会呼吸的，鲜活的生命体，我们旨在为肌肤寻找到新的护理方法，从而帮助您树立自信并带来全面的健康。通过为肌肤提供前所未有的，可持续的解决方案，我们的出现是对全球美容行业的一次大挑战。
这种新的方法主要是通过大胆的创新为用户带来实实在在的，持久的皮肤健康。我们从不模棱两可雾里看花，我们会清楚地说明我们的产品所带来的好处，因为他们确实会像我们所描述的那样为您的肌肤带来神奇的变化。我们根据皮肤病和美容的最新研究，只和最有资格的专业人士合作，这种以结果为导向的做法也使得我们在竞争对手当中脱颖而出。
突破性的技术，完美的服务，良好的信誉都将帮助我们赢得广大客户的忠诚。当然，最终还是因为我们产品的卓越品质，将使得人们在讨论美丽肌肤的潜力时，第一个浮现于脑海的品牌就是FOREO。
Contact Us
Main offices are as followed.
1. FOREO AB
Birger Jarlsgatan 22
Stockholm 114 34
Sweden
P: 408 249 4000
F: 408 404 7111
2. FOREO INC.
3565 LAS VEGAS BLVD. S #159
LAS VEGAS, NV 89109
3. FOREO (HK), ltd.
UNIT H2. 18/F. GOLDEN BEAR IND
CfR. NOS 66-82 CHAI WAN KOK
ST, TSUEN IVAN, NEW TERRITORIES
HONG KONG
4. FOREO Oceania Pty Ltd.
Level 14, 210 George Street
Sydney NSW 2000
Australia.
5. FOREO (Shanghai) Trading ltd.
F7, Guobang Garden, No. 10, Lane 396 South Wulumuqi Road
Shanghai
China
Find out more at www.foreo.com .
FOREO’s significance surpasses the cosmetic – by treating the body as a living, breathing whole, caring for the skin becomes a new style of living that promotes confidence and total well-being. With unprecedented solutions that map the future of sustainable, long-term skincare, our challenge to the beauty and wellness industry is global in scale.
This new approach is centered on radical innovations that bring tangible, lasting enhancements to the health of the skin. Without resorting to smoke and mirrors, we explain and illustrate the benefits of our products clearly, because they work precisely as effectively as we claim. Informed by the latest dermatological and cosmetic research, in collaboration with the most qualified professionals, we adopt a results-oriented approach that sets us apart from our competitors.
Groundbreaking technology, immaculate service, and the credibility that flows from communication of genuine substance will all help us to win the loyalty of our customers. Yet ultimately it will be the superiority of our products that will make FOREO the first name on people’s minds when discussing the potential for beautiful skin.
关于斐珞尔
BEAYTY BEYOND COSMETICS 不仅仅是化妆品
FOREO是一家设计、生产和销售护肤仪器的瑞典公司。FOREO产品系列于2013年在中国正式启动，经过10多年的研究和发展，依靠皮肤科医生、细胞生物学家、美学家和机械工程师的专业知识，为各方面的护肤和健康需求提供高品质有效的解决方案。
首次推出的LUNA抗衰老和面部清洁刷系列，FOREO的定位就是在保证产品质量卓越的基础上给人们的生活带来难以想象的改善。通过遍布美国，欧洲和亚洲的完善的销售渠道，我们很高兴与全球客户分享我们革命性的护肤方法。
FOREO系列的问世对美容行业具有里程碑式的意义 ，因为我们把身体看做一个会呼吸的，鲜活的生命体，我们旨在为肌肤寻找到新的护理方法，从而帮助您树立自信并带来全面的健康。通过为肌肤提供前所未有的，可持续的解决方案，我们的出现是对全球美容行业的一次大挑战。
这种新的方法主要是通过大胆的创新为用户带来实实在在的，持久的皮肤健康。我们从不模棱两可雾里看花，我们会清楚地说明我们的产品所带来的好处，因为他们确实会像我们所描述的那样为您的肌肤带来神奇的变化。我们根据皮肤病和美容的最新研究，只和最有资格的专业人士合作，这种以结果为导向的做法也使得我们在竞争对手当中脱颖而出。
突破性的技术，完美的服务，良好的信誉都将帮助我们赢得广大客户的忠诚。当然，最终还是因为我们产品的卓越品质，将使得人们在讨论美丽肌肤的潜力时，第一个浮现于脑海的品牌就是FOREO。
Contact Us
Main offices are as followed.
1. FOREO AB
Birger Jarlsgatan 22
Stockholm 114 34
Sweden
P: 408 249 4000
F: 408 404 7111
2. FOREO INC.
3565 LAS VEGAS BLVD. S #159
LAS VEGAS, NV 89109
3. FOREO (HK), ltd.
UNIT H2. 18/F. GOLDEN BEAR IND
CfR. NOS 66-82 CHAI WAN KOK
ST, TSUEN IVAN, NEW TERRITORIES
HONG KONG
4. FOREO Oceania Pty Ltd.
Level 14, 210 George Street
Sydney NSW 2000
Australia.
5. FOREO (Shanghai) Trading ltd.
F7, Guobang Garden, No. 10, Lane 396 South Wulumuqi Road
Shanghai
China
Find out more at www.foreo.com .