罗氏
MSAT Qualification Lead
MSAT Qualification Lead
发布于 大约 3 小时前基层主管/组长
上海市
高级经验
全职员工
仅现场办公
本科
质量管理
English
GMP
cGMP
MSAT
Leadership
Validation
AI 估算 · 25k–40k
跨国药企上海Lead级别，要求5-8年经验，薪资竞争力强，市场范围约25-40k/月。
职位详情
关于这个职位
作为罗氏上海的MSAT Qualification Lead，您将负责新设施的设计、调试与验证，以及GMP设备的定期评审和变更触发的确认工作
您需要领导团队执行确认活动，确保符合cGMP法规，并为内外部审计提供支持
该职位要求深厚的制药行业确认经验和技术领导力
最低要求
Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above
or more years qualification experience, 8 or more years MSAT/Technical or qualification experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
Demonstrated experience in strategic thinking, exceptional customer service skills; highly skilled in negotiations, collaboration, and influencing
Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification
Strong communications skills including the ability to communicate fluently in English, both verbally and written
Strong business acumen, communications, and analytical thinking required
Strong interpersonal, leadership, collaboration and conflict resolution skills
Experienced in new facility startup readiness and operation ramp
Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
Project management skills and Leading team capability preferred
Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
Knowledge of Quality management
工作职责
Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward-thinking outlook; remove barriers
Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion
Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities
Contribute to a culture of continuous improvement and model lean leadership principles
Contribute to a culture of transparent, high performance, empowerment and innovation culture
Acts as a mentor and coach to less experienced colleagues
Participate in the design and construction of new facilities, including but not limited to URS review, FAT, SAT, IOPQ, tech transfer and other aspects related to MSAT activities
General Customer Service: Identify the customers that are the recipient of the service delivered. Utilize tools such as CRM/Helpdesk, SPOC
Support Other Colleagues within the team: Support other colleagues within the qualification team as required (such as Time-based Requalification)
Periodic Review Execution: Execute periodic review of GMP equipment, including protocol, and getting approved
Qualification triggered by Change: Execute qualification triggered by change accordingly, include protocol, and getting approved
CSV Execution: Supervise Testing and Execute Testing in CSV
Periodic Assessment: Execute periodic assessment as required
Qualification Planning and Report: Execute qualification plan and report, include protocol, and get approved
Independently finish qualification activities and solve the relative issue, give guidance to the other engineer in the team
Coordinate Qualification Implementation within technical division
Provide the technical expertise for routine work and for Site Master Plan projects and Site Engineering projects as well
Prepare, review and approve specific qualification summary sections of regulatory submissions. Present the qualification program to regulatory authorities during routine and pre-approval inspections
Ensure timely and accurate qualification data analysis, review, reporting and trending of data
Recommend actions to address adverse findings and/or identify cost effective modifications to current processes
Other tasks assigned by the manager
优先资格
People management experience is a plus
Prior experience in validation is advantageous
Experience leading major change initiatives strongly preferred
AI 洞察
优缺点分析
优点
- 罗氏作为全球制药巨头，提供完善的培训体系和职业发展机会
- 参与前沿的无菌灌装设施项目，积累高端技术经验
- 职位兼具技术深度和管理广度，适合提升综合能力
- 公司文化强调多元化、包容性和创新，工作环境开放
- 对法规合规性要求极高，一旦失误可能导致重大影响
- 需要同时管理技术细节和战略规划，对多任务处理能力要求高
- 适合有5年以上制药确认经验、希望向技术领导角色转型的资深工程师或主管
缺点 / 挑战
- 需要承担较大的项目责任，特别是在新厂启动阶段，工作强度可能较高
角色解读
- 可在MSAT领域深耕，成为技术专家或高级经理
- 向更广泛的制造科学与技术管理岗位发展，如MSAT总监
- 跨部门转向质量保证或监管事务，利用丰富的合规经验
- 负责新工厂的设计、调试和确认工作，参与URS审核、FAT/SAT/IOPQ等技术转移活动
- 执行GMP设备的周期性评审、变更触发的确认以及CSV测试，确保合规性
- 为团队提供技术指导和辅导，支持日常确认活动并解决复杂的技术问题
- 准备和审核法规申报中的确认部分，并在审计中向监管机构展示确认程序
- 深厚的制药行业确认经验，特别是无菌灌装设施的验证和启动
- 精通cGMP法规和质量管理体系，能够主导内外部审计
- 出色的英语沟通能力（口语和书面），以及跨部门协作和影响力
- 战略思维和项目管理能力，能够将策略转化为可执行计划
申请策略
- 仔细研究罗氏的企业文化和MSAT部门的业务方向，在面试中展现文化契合
- 准备至少一个复杂的确认问题解决案例，展示技术深度和领导力
- 突出无菌灌装设施验证、新厂启动和cGMP合规的具体项目经验
- 强调领导力案例，如团队指导、跨部门协作或变更管理
- 量化成果，如减少偏差、提升效率或通过审计的实例
- 展示英语水平和跨国合作经验
- 补充项目管理认证（如PMP）或精益六西格玛知识
- 深入学习生物制药行业最新法规（如ICH Q9、Q10）
面试指南
- 使用STAR法则（情境、任务、行动、结果）结构化回答行为问题
- 对于技术问题，先明确法规依据，再结合实际操作步骤，最后强调质量风险
- 领导力问题突出团队赋能和冲突解决，展现VACC模型的应用
- 请描述您参与过的最复杂的确认项目，您是如何领导和协调的？
- 在新厂启动中，您如何平衡进度与合规要求？
- 当团队成员对确认方法有分歧时，您如何处理？
- 请解释cGMP中关于变更控制的要求，并举例说明
- 您如何看待MSAT部门在制药企业中的角色？
职位点评
69
综合评分
跨国药企lead级确认岗位，薪资竞争力强，技术前沿，但办公现场且WLB一般。
更适合这类人
适合优先考虑职业发展、薪资待遇和社会价值，对工作生活平衡要求不高的资深专业人士。
表现最好
薪资福利
相对薄弱
工作生活
薪资福利80
成长发展75
工作生活50
使命价值70
薪资福利
80较高
罗氏作为跨国药企提供具有竞争力的薪资和福利，但JD未明确具体数字，薪资信号为未披露，福利未提及。
薪资信号未披露（AI估算：25K-40K/月）
成长发展
75中等
职位涉及新技术（无菌灌装设施）和领导力培养，有导师角色，但JD未明确提及晋升通道或培训。
技术前沿主流现代技术
技术栈MSAT、Qualification、GMP、cGMP、Validation、Aseptic Filling、CSV
成长机会mentor、coach
业务类型profit_center
工作生活
50较低
仅现场办公，未提及弹性工作或WLB福利；上海张江药谷可能位置偏远，通勤压力较大。
工作模式仅现场办公
办公地点科技园/产业园
加班情况未提及（无法判断）
使命价值
70中等
制药行业关乎患者健康，社会价值较高；公司强调使命和多样性，但JD未明确社会影响具体描述。
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号advancing and boldly championing diversity, equity, and inclusion
创新程度积极采用新技术
Watch Jobs