南京招聘

【业务扩张，新增职位】

Global Technical Consultant，

工作地点：上海市中心

要求：

1. 英语流利，和国外总部直接汇报

2. 熟悉洁净室的标准和规范

3. 熟悉EN/AOAC的标准

4. 精通中国GMP法规和中国制药行业的其他法规/指南

Provide technical expertise across a broad base of applications to resolve complex customer problems in cleanrooms and manufacturing applications

Conduct customer technical visits and site surveys, reviewing customer processes and the cleaning and disinfection products in place to ensure they are both compliant and as efficient. Making documented recommendations and supporting any change

Assist the customer in their change control process including technical documentation for SOP’s, Validation, Training

?Conduct customer-facing seminars and internal training on GMPs, microbiology, efficacy testing and cleaning and disinfection

Interface directly with Corporate Account Managers to ensure deliverables meet the customer needs. Take part in sales presentations and support

?Assist in communicating best practices and key learnings to the greater field organization

Provide leadership on unique customer projects which are beyond the expected technical ability of Account Managers or Regional Managers

?Responsible for ensuring brand standards and awareness, accuracy and compliance of reports in a timely manner

任职条件

?Bachelor of Science degree in Life Sciences, preferably in Microbiology

?Minimum of 5-8+ years of practical experience in Microbiology

?Experience in understanding/troubleshooting of cleanroom operations

?Ability to travel 50%+ within China/APAC based on customer needs

?Excellent oral and written communication skills, interpersonal and problem-solving skills

?Fluent in both Mandarin and English

【Preferred Qualifications:】

?Master’s degree in Microbiology

?Experience or familiarity with the Life Sciences industry (Pharmaceutical)

?Demonstrated proficiency with internal or external auditing

?Experience in change control processes

?Ability to take initiative, work independently and prioritize multiple projects with strong follow-through

?Flexibility to work on and control different projects at the same time while still meeting set deadlines

?Good knowledge of EN/ AOAC standard test methods and mode of action of disinfectants

?Previous experience in GMP production sites

?Understand Chinese GMP regulation and other regulations/guidelines of Chinese Pharmaceutical Industry

?Understanding regulatory compliance frameworks (e.g. MHRA, FDA, HPRA)

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