Engineer QC
Posted on :
12-12-2024
Employer Active
1 Vacancy
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Job Description
- Responsibilities
- Provide quality expertise support to projects and factories.
- Assisted in the development of GPQS, ECMS, GVLMS databases and provided expertise.
- Support and drive necessary departmental processes, documentation and training.
- Support and maintain technical capabilities and collaborate with peers in Engineering, IT, QA, Manufacturing and Technology functions to provide quality oversight on assigned projects and activities.
- Support quality control work of GMP related facilities and equipment systems to ensure full compliance with GMP.
- Strictly implement job operating procedures and guidelines to complete daily experiments.
- Participate in GMP training and strictly abide by GMP and regulatory requirements
- Develop various job skills and pursue continuous improvement
- Complete other work as required by the business
- Provide quality expertise support for the project and the plant.
- Support the development of GPQS, ECMS, and GVLMS databases, providing expertise.
- Support and drive necessary departmental processes, documentation, and training.
- Support and maintain technical capabilities, and collaborate with peers in engineering, IT, QA, manufacturing, and technical functions to provide quality oversight in designated projects and activities.
- Support quality control work for GMP-related facilities and equipment systems to ensure full compliance with GMP.
- Follow job operating procedures and guidelines to complete daily experiments.
- Participate in GMP training and strictly comply with GMP and regulatory requirements.
- Develop various work skills and pursue continuous improvement.
- Requirements
- Possess a bachelor's degree and general experience in pharmaceutical quality, manufacturing, technology.
- Basic knowledge of cGMP and Global GMP requirements, quality systems, and drug/device testing techniques and pharmacopoeias.
- Possess basic knowledge of computer validation and 21 CFR 11.
- Possess good interpersonal and problem-solving skills.
- Ability to handle multidisciplinary and multi-functional work both independently and collaboratively.
- Use Chinese and English as working languages.
- Possess excellent verbal and written communication skills and the ability to communicate effectively with individuals at all levels of the organization.
- Bachelor’s degree and general experience in pharmaceutical quality, manufacturing, or technical roles.
- A basic knowledge of cGMPs and global GMP requirements, quality systems, and pharmaceutical product/device testing technology and pharmacopeia. Well -developed interpersonal and problem-solving skills.
- A basic knowledge of computer validation
- Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional.
- Use both Chinese and English as working language.
- Excellent oral and written communication skills with the ability to communicate effectively with individuals from all levels of the organization.
Employment Type
Full-time
Department / Functional Area
Key Skills
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