Quality Responsible Person, EM CHC China MAH
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- 上海
Job title: Quality Responsible Person, EM CHC China MAH
- Location: Shanghai
- 80% onsite & 20% travel
- Job type: Permanent
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About us
At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing “Health in Your Hands”.
We are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast Moving Consumer Healthcare (FMCH) Company In & For the World”.
Consumers at the heart of everything we do and we want to make a difference where it counts, driving leadership in the categories we play in: Allergy, Digestive Wellness, Pain, Physical & Mental Wellness, and Cough, Cold & Flu.
To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world.
About the job
The Quality Responsible Person (QRP) EM CHC China shall manage the quality and compliance activities of the EM CHC China MAH Quality team. The QRP shall manage the EM CHC China Quality team’s participation in quality management activities such as establishment and continuous improvement of the quality system, self-inspection, external quality audit, validation, adverse drug reaction reporting and product recalls, in collaboration with the Head of Quality, EM CHC AMEA & China and the extended EM CHC AMEA Quality team.
The QRP EM CHC China shall serve as the functional quality representative and senior Quality manager to ensure that CMOs / third party /suppliers are approved and that contracted Good Manufacturing Practices (GMP) activities are in compliance with international and local regulatory requirements, MAH License, quality agreement, the registered dossier, and Company local and global quality documents when applicable.
The QRP shall contribute to business operation by establishing partnerships and establishing trust with the CMOs / third party /supplier business partners and providing quality oversight and support for quality operations activities. The QRP shall escalate activities, issues, progress to Head of Quality, EM CHC AMEA & China.
The QRP is responsible for direct management of the EM CHC China Quality team members and their activities to meet the Good Manufacturing Practice for Drugs requirements for the MAH License. The QRP will manage and lead the EM CHC China Quality team to meet quality management requirements so that all registration requirements related to drug safety, efficacy and quality are systematically implemented throughout the entire process with oversight of the third party CMO production, control, product release, storage and distribution, to ensure that the products are manufactured in accordance with the registration requirements and are suitable for their intended use.
The QRP shall ensure regular monitoring, assessment of records and results related to the contracted GMP activities.
The QRP shall ensure that the quality team participate in all quality related activities and review all GMP related documents when required.
The QRP shall hold and manage responsibilities as the Qualified Person (QP) for management of product release activities and to ensure that the production and testing of each batch of released products are in accordance with the related regulations, the registration requirements, and specifications. The QP activities and tasks may be delegated to designated Quality Managers of a satisfactory qualification level within the EM CHC China Quality team. Prior to the release of each batch, the designated QP must issue a review record for product release according to the requirements.
The QRP will plan, organise and coordinate their workload and that of their Quality team members within the EM CHC CHINA hub, so as to ensure that all routine scheduled work is carried out in a cost-effective and timely manner to GxP and regulatory guidelines and to Company procedures. The QRP will have responsibility to ensure that their EM CHC CHINA hub meets Quality Key Performance Indicators, in line with Organisational and Regulatory Standards and will take part in Quality and Regulatory Audits if required.
The QRP shall facilitate the empowerment of the EM CHC China Quality team members for operational quality decision making, without compromising the Quality System &/or Standards through implementation and adherence of the Quality Documentation, Quality Systems Management and Quality Technical Support.
The QRP will collaborate across the full EM CHC AMEA & China entity to assist and support leadership and Quality workload as required to drive continuous improvement and efficient compliance.
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, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com
