Job title: Sterility assurance lead
- Location: Beijing
About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Sterility assurance lead within our M&S China-BEI Site, will be making best class medicines with excellent strategies and tools and delivering them to our patients.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities
• Developing and implementing comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives
• Developing and implementing effective strategies and procedures for sterility assurance and microbiology across the organization (environment, water, steam, gas, bio-cleaning, gowning, aseptic processes and practices and industrial supplies, etc.) and Qualification/Validation for processes (microbio strategy)
• Ensuring the compliance of products and processes with applicable sterility assurance and microbiology regulatory requirements and company quality standards
• Maintaining a system to ensure sterility assurance and microbiological risks are properly identified, tracked and mitigated
• Overseeing of production activities as (MFT, best aseptic practices ....)
• Overseeing, with Q&V team, the validation, qualification, and monitoring of methods, equipment, and the environment ensuring sterility assurance control
• Following metrics and monitoring data for the sterility assurance and microbiological activities to identify trends and issues and to implement action plan
• Establishing and monitoring key performance indicators (KPIs) and metrics for the sterility assurance and microbiological activities and reporting on its performance and effectiveness
• Promoting a culture of quality throughout the organization
• Identifying and driving continuous improvement initiatives and projects to enhance the sterility assurance and microbiological activities
• Evaluating and recommending new technologies, tools, and methods to enhance sterility assurance and microbiology
• Leading management reviews to assess the effectiveness of the sterility assurance program and microbiological program
• Leading and managing the sterility assurance and microbiology team, including hiring, training, coaching, professional development, and performance evaluation
• Interacting with external bodies and Global Quality to bring knowledge and awareness of best industry practices (Congress, CoP and CoE)
• Preparing and participating in regulatory inspections and audits, providing expertise on sterility assurance and microbiology
• Providing support for the successful collaboration between Digital, Quality, and technical functions to achieve desired functionality, compliance, and productivity for new solutions in Sterility Assurance and Environmental Monitoring areas
• To ensure the operations in environmental monitoring fulfill the GMP requirement. Prepare the relevant specifications and analytical test methods to ensure the routine monitoring of the manufacturing area is correctly performed.
• Be responsible to projects and continuously improvement, validation and investigation in EM and sterile assurance
• Support in implementation of contamination control strategy (CCS) and sterile product manufacturing to prevent contamination, and contribute to the trouble shooting for sterility/microbe contamination issue in EM, equipment, utility, material, product and production related validation etc.
• Developing or assisting the develop microbial/EM assessment SOP to support routine operation, e.g. EM and utility monitoring and testing.
• Ensure that monitoring is carried out in compliance with specifications, Pharmacopeia requirements and the cGMP and analyse the trend of the analytical results. Ensure the exceeding limit investigation is conducted properly.
• Keep close relationship and communication with other departments to ensure proper execution of the production plan.
• Implement GAP analysis for global requirement and local authority standard and take CAPA actions related to EM, CCS and gowning.
• Support in clean zone re-construction, process optimization, people's awareness enhancement, utility control from contamination control and microorganism monitoring perspective.
• Participate in the investigation for sterility/microbe contamination issue in EM, equipment, utility, material, product, APS etc.
• Support in implementation of the CCS (contamination control strategy).
• Support in technical training deployment in site level regarding to the contamination control.
• As SA role, participate in the expert assessment regarding contamination control related change control.
• Participate in related inspection, to answer auditor's questions as Sterility Assurance SME, and corporate with such as production and engineering department to answer SA related questions.
• Responsible for following the company's HSE policy and integrated all requires into daily work. Incorporate HSE work into the work plan
• Participate the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.
• Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.
• Timely working out of employee opinions.
• Participate in department-level HSE education and assessment work; handle employee feedback in a timely manner.
• Actively cooperate with HSE management to prevent accidents from happening.
• Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.
• Participate in accident investigations, analyze the root causes of accidents from a quality management perspective, and propose related CAPA.
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Pursue Progress. Discover Extraordinary.
Progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!