Website Sanofi Global
Discover Sanofi: a global biopharmaceutical company focused on human health.
Grow Chinese talents in short/mid term in order to support business growth in China, 3-5 years program for high potential Chinese talents with strong academic background to reach leadership positions in China or in global organizations. This position may go through below job rotations during the program, and may be adjusted base on business and program needs.
- Quality (12 months)
- Production (9 months)
- SP international site Production (12 months)
- SZ Site Head Assistant (12 months)
- 1 global role in Lyon VIA strategy team (6 months)
(4 to 6 key accountabilities):
1. Review and approve all quality related changes; Ensure all significant deviations and out-of-specification results are timely investigated and handled; Ensure all quality related complaints are timely and properly investigated and handled; Ensure that the product quality reviews are done; Ensure self-inspection is done; Assess and approve material suppliers; Review and co-operating product recall under the guidance of company policy; To be involved in the quality related activities, with veto rights;
2. Ensure that all necessary testing is carried out; Ensure that all starting materials, packaging materials, intermediate, bulk and finished products meet the registration requirements and specifications; Approve specifications, sampling instructions, testing methods and other quality management procedures; Approve and monitor any contract analysis; Ensure the implementation of on-going stability study and make the stability data available; Confirm and monitor the storage condition for materials and products; Responsible for the release or rejection of all the raw materials, intermediate products, semi-finished products, bulk products, finial bulk products and finished products;
3. Review and approve all the documents for technology procedures, production SOPs; Ensure the batch records are reviewed before product release; keep all the production records and testing records
4. Ensure the necessary qualifications or validations are done appropriately, review and approve the qualifications or validations protocols and reports; Ensure all the manufacturing processes were validated; Ensure all the analytical methodologies were validated; 5. Ensure the necessary initial trainings when boarding and the continuing trainings to the Quality Control staff and Quality Assurance staff and related staff in the company are carried out and adapted according to need.
6. Supervise the maintenance of workshops and facilities for the purpose of maintaining a sound operating state; Supervise the sanitary conditions of the sites; Monitor the elements impacted to the product quality; Ensure the drug manufacturing and quality management in compliance with GMP requirements.
7.Participate in setting up enterprise quality system, internal auditing, external quality auditing, validation and adverse drug reactions reports, recall products and other quality management activities.
Education and experience
Specific degree, duration of experience (Required to hold the job):
1. Should at least have a Bachelor’s degree in pharmaceutical or related major (or having intermediate professional technical title or Licensed pharmacist), having at least 5 years of working experience in pharmaceutical industry and with at least with 1 year working experience in pharmaceutical quality management. And having pharmaceutical production process control and quality inspection experience.
2. Have been educated with necessary professional theorty knowledge and have been received related training of product releasing, which can independently conduct duty.
Key technical competencies and soft skills:
1. Fluent in both written and spoken English;
2. Good leadership and management skills;
3. Strong expertise in GXP environment.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
To apply for this job please visit en.jobs.sanofi.com.