Quality Engineer II

Abbott; Kampung Tong Prok; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading nutrition company in Malaysia is looking for a Regulatory Compliance Specialist to oversee compliance issues for infant formula and related products. The ideal candidate will collaborate with quality assurance, prepare regulatory documentation, and track regulatory developments in China. A Bachelor's degree in food science or related field is required alongside experience in GMP and food safety regulations. Strong communication skills in both spoken and written English are essential for this role.

Qualifications

• Bachelor Degree and above in food science, food technology, food analysis or related subjects.
• Good practical knowledge of GMP, food safety regulation, GB compliance in infant formula food.
• Fluent spoken English and sufficient written communication skills.

Responsibilities

• Coordinate regulatory compliance issues within the quality department.
• Responsible for external application and registration dossier preparation.
• Track and assess newly revised regulations in China.

Skills

Knowledge of GMP

Food safety regulation

Fluent spoken English

Written communication skills

Education

Bachelor's degree in food science or related field

Job description

JOB DESCRIPTION:

主要职责
Core Job Responsibilities

• 作为法规合规专家参与公司的各种项目工作，协调QA、RA部门对各个项目的支持工作。
• Participate in projects of plant or affiliate as regulatory compliance representative, coordinate QA or RA issues within quality department and reach out to regulatory department.
• 准备外部申报/注册资料如生产许可证、CIQ证书、FSMP及IFM注册申报等，与外部机构办事人员联系申报事项。
• Prepare dossier for external application/registration such as ML, CIQ, FSMP, etc. Communicate with external agency contactor for application issues.
• 负责工厂法规方面SOP及文件的维护，及对工厂的法规培训工作。
• Responsible for plant regulatory SOP and documents maintenance, responsible for plant regulatory compliance training activities.
• 跟踪中国法规发展趋势，组织跨部门团队进行差距分析，并制定行动计划。
• Track newly issued or revised chinese regulations, have gap assessment and coordinate actions with cross function team.
• 参与支持质量体系的其他工作，如内审等。
• Maintenance site integrity management system, participate and support quality system related work, for example, internal audit.
• 负责管理政府现场取样工作。
• Responsible for managing government on-site sampling work.

职位职责/范围 Position Accountability / Scope

• 向法规合规主管汇报，协助婴幼儿配方乳粉、特殊医学用途配方食品及其他相关产品的法规事务。
• Report to regulatory compliance supervisor, responsible for regulatory issue of IFM products, FSMP and other products in JX plant.
• 组织内部相关部门，准备向外部机构的申请或注册工作资料，并协助完成各项内审、外审活动。
• Ensure compliance of plant operation and successful application/registration in external agency including FDA, MOH, CIQ, etc.

最低学历要求 Minimum Education

食品科学、食品工程、食品分析等相关专业，本科及以上学历。

Bachelor Degree and above in food science, food technology, food analysis or related subjects.

最低经验/培训要求 Minimum Experience / Training Required

• 对GMP、食品安全法规、婴幼儿配方乳粉、特医食品及乳制品国标有较好了解。
• Good practical knowledge of GMP, food safety regulation, GB compliance in infant formula food, FSMP and dairy food manufacturing.
• 对HACCP、诚信体系、ISO9001等体系管理知识有较好了解。
• Have good knowledge in HACCP, Integrity Management System, ISO 9001 etc, system.
• 对食品生产过程及工艺有较好了解。
• Have good understanding of food manufacturing process.
• 具备流利的英语口语及充足的书面沟通能力。
• Fluent spoken English and sufficient written communication skills.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality  DIVISION: ANSC Nutrition Supply Chain  LOCATION: China > Jiaxing : 681 Shengtang Road  ADDITIONAL LOCATIONS:

WORK SHIFT: Standard  TRAVEL: Not specified  MEDICAL SURVEILLANCE: Not Applicable  SIGNIFICANT WORK ACTIVITIES: Not Applicable