M&S-QA Specialist-Shenzhen

Job description

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

·  Set clear direction & aligns team & others, around common objectives
·  Inspire continuous improvement & breakthrough thinking, display analytical &conceptual thinking
·  Have broad presence and resources within large platform to broaden global view sight

What you can contribute?

1.    Ensure the fully compliance of site manufacturing, laboratory process with current GMP regulation, Sanofi global quality guildline or registration dossier, including responsibility but not extrausted below:

-      Production, lab area oversight, and related CAPA follow up;

-      Review of SOP and batch production/test record;

-      Deviation handling, supervise the investigation process and CAPA definition;

-      Fully invovled change control evaluation, self-inspection and quality plan activities.

2.    Maintain site validation valid condition of facility, equipment and process, to ensure the compliance with current GMP regulation, Sanofi global quality guildline, including responsibiity but not extrausted below:

-      Review validation protocol/report. Provide technical support and supervision during the execution.

-      Site validation activities follow up to maintain the fluent running of site VMP;

-      Responsible for the establishing of site validation strategy SOP;

3.    Organize the drafting and approval of the anually product review report, EM and clean utility retrospective report.

4.    Responsible for the cold chain data management.

5.    Take part in the construction and maintenance of Site Quality Culture.

6.    Any other works as assigned by line manager.

What you should have?

Specific degree, duration of experience (Required to hold the job):

1. At least a Bachelor degree in Biologic/Chemical/Pharmacy, or related science discipline.

2. At least 3 years of relevant experience in the pharmaceutical industry, preferably in Biologics.

3. Validation experience in advantage.

Key technical competencies and soft skills:

1. Computer skill: word, excel, powerpoint at least.

2. English: Oral, read and writing skill.

3.Good professional knowledge base.

4.Performance and achievement oriented.

5.Good communication and coordination skill.

If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

·  Exercise good judgment & drives change for competitive advantage
·  Drive for superior results & has passion to win
·  Build the talent pipeline and develop others

Able to burden pressure, result driven

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.