锦鲤求职岗位描述
在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。
职位
Engineering Project Support and Operation Readiness:
CCS Support: Support the establishment of the Contamination Control Strategy (CCS) for the aseptic production line.
Environmental Monitoring (EM): Support EMPQ and establish risk based environmental monitoring strategy and ensure its effective implementation.
Microbiology Method Validation: Responsible for the validation of microbiology methods, including supporting the confirmation of cleaning and disinfection processes, and the efficacy of disinfectants.
Lab Setup: Lead the setup of a microbiology laboratory that complies with regulatory requirements and build a BSL-II (Biosafety Level 2) lab management system.
Equipment Support: Support the Performance Qualification (PQ) of laboratory equipment and ensure routine operation.
Routine Operation:
Compliance Leadership: Lead the execution and oversight of environmental monitoring and critical facility testing in accordance with Chinese GMP, EU GMP, U.S. cGMP regulations, and Roche/Genentech standards.
Methodology Management: Lead the continuous effort to ensure all microbiological test methods are validated and that their validation status is maintained as effective.
Audit Readiness: Be accountable for audit readiness by ensuring compliance with effective standards and regulatory/statutory guidelines. Actively lead the team's response to regulatory inspections and global quality audits.
CCS and Training: Drive the continuous support of the effectiveness of the Contamination Control Strategy (CCS) and lead the organization of microbiology-related training.
Product Release Leadership: Be accountable for product release testing, ensuring timely delivery according to lead time requirements and guaranteeing compliance with Data Integrity (DI) standards.
Team Development: Lead the development of a competent team through coaching, mentoring, and training by having a skills competencies development and appraisal program in place to strengthen the technical expertise and capabilities.
Qualification and Experience
Education/Qualifications
Bachelor’s Degree (Life Sciences, Microbiology, or Analytical Sciences is preferred) and above
Special Equipment management certification
Leadership Competencies
Take a genuine interest in people
Listen carefully, tell the truth, and explain the why
Empower and trust people to make decisions
Discover and develop the potential in people
Strive for excellence and extraordinary results
Set priorities and simplify work
Congratulate people for a job well done
Job Required Competencies
5 or more years of QC experience, QC experience, with a focus on microbiology and aseptic processes. MNC Bio-pharma experience is preferred
3 or more years of People management experience
In-depth knowledge of quality control procedures and legal standards, with extensive experience in aseptic assurance and microbiological testing. Possess hands-on experience in Contamination Control Strategies (CCS) and Environmental Monitoring (EM) control strategies.
Advanced knowledge of regulatory requirements in the industry. Experience with compliance inspection by NMPA/FDA/EMA/TGA/PMDA.
Experienced in strategic project of QC design, commissioning & qualification. Experienced in QC new facility startup readiness and operation ramp up including organization, people and operation management system.
Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
我们是谁
打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。
让我们一起，构建更健康的未来。
罗氏提供平等的职业发展机会。