Regional Quality Documentation Specialist

Job Posted 2 Days Ago Posted 2 Days Ago
Be an Early Applicant
Petaling Jaya, Petaling, Selangor
Junior
Healthtech
The Role
The Regional Quality Documentation Specialist will manage quality document deliverables, support documentation practices, and coordinate processes in a GxP environment.
Summary Generated by Built In

About the job  

 

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.   

 

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.  

 

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.  

 

Main responsibilities: 

  • With a focus on initiation of quality documents (QD) deliverables 

  • Create DocID in QualiPSO and metadata: manage the creation & update of metadata 

  • Implement updates of applicability of the documents and stakeholders, update picklist (e.g. material, buildings, etc…) 

  • Implement communication strategy based on local document governance 

  • Coordinate transversal Content Management System (CMS) QualiPSO administration – check user access and privilege (care request management), training assignment and annual review access 

  • Support good documentation practices training and communication 

  • Support document change request (DCR) process – Support monitoring of DCR process including KPI, DCR sharing for decision (to author and local Doc Controllers) 

  • Support periodic review by monitoring periodic revision process with KPI, interaction with Author/local Doc Controllers, launch of periodic revision process in the tool  

About you  

  • Experience: >1 yrs professional experience in documentation, in GxP environment ´ 

  • Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments 

  • Technical skills: Strong skills in Quality DMS, Word, Excel, Powerpoint 

  • Education: Good administrative experience,  Bachelor Degree preferrable 

  • Languages: Excellent English communication and writing 

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!

Top Skills

Excel
PowerPoint
Qualipso
Quality Dms
Word
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Paris
85,000 Employees
On-site Workplace
Year Founded: 1973

What We Do

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms

Similar Jobs

Petaling Jaya, Petaling, Selangor, MYS
85000 Employees

Mondelēz International Logo Mondelēz International

People Lead - SEA MSC Projects & Governance

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Remote
Hybrid
11 Locations
90000 Employees

Mondelēz International Logo Mondelēz International

SEA BU MSC Projects and Digitalization Manager

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Hybrid
4 Locations
90000 Employees

UL Solutions Logo UL Solutions

Senior Sales Executive (Appliances, HVAC & Lighting)

Automotive • Professional Services • Software • Consulting • Energy • Chemical • Renewable Energy
Hybrid
Subang Jaya, Petaling, Selangor, MYS
15000 Employees

Similar Companies Hiring

Mochi Health Thumbnail
Telehealth • Healthtech
San Francisco, CA
70 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees
Stepful Thumbnail
Software • Healthtech • Edtech • Artificial Intelligence
New York, New York
60 Employees
Not Eligible
Save
By clicking Apply you agree to share your profile information with the hiring company.

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account