Responsibilities

• Bachelor or above degree in Life sciences/Computer Sciences, or related field.
本科或以上学历，生命科学/计算机科学或相关领域。
• At least 3+ years of working experiences in the field of computerized system validation and computer system quality in the pharmaceutical industry. Certifications in computer system quality and quality management preferred.
至少拥有3年以上在制药行业的关于计算机系统验证和计算机系统质量领域的工作经验。用于计算机系统质量和质量管理专业证书的人员优先。
• Deep knowledge and expertise in related regulatory requirements and industry standards, such as 21 CFR Part 11/210/211, Annex 11 of EU GMP, Appendix I of CFDA GMP, GAMP 5, and ICH Q9/Q10.
对于相关的法规要求和行业标准有深刻的理解和认识，如21 CFR Part 11/210/211，欧盟GMP Annex 11，中国GMP Appendix I，GAMP 5和ICH Q9/Q10。
• Strong communication and presentation skills.
较强的沟通及表达能力。
• Working knowledge of project management and system implementations.
具备项目管理及系统实施方面的工作认知。

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.