Quality Assurance Operational Support - Senior

Job title: Quality Assurance Operational Support – Senior

• Location: Bogotá

About the job

Our Team:

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:

- Verify that parameters, op. conditions and acceptance criteria are defined (per SOP)

- Collect electronically stored data (e.g., from suppliers)

- Describe project details

- Ensure data integrity and adherence to quality rules are regulations

- Fulfil template according to equipment type & specific requirements

- Prepare data for analysis conducted by qualification expert

- Schedule formal consolidated review & approval meetings

About you

· Experience: Professional experience of at least 3 years in data analytics or qualifications-validations within validation departments in the pharmaceutical sector, medical devices, biotechnology. Experience in equipment qualification documentation management: VP, URS, IQ, OQ, PQ. Validations (Analytical o process): protocols and validation reports.

· Soft & Technical skills: Proficient in attention to detail, Organizational skills, Time management, Written communication, Problem-solving abilities, Teamwork and collaboration, Adaptability, Accountability and consistency, Basic analytical thinking. Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point & data analytics

· Education: Bachelor's degree (preferably in pharmacy, engineering, chemistry, biology, or related field.

· Languages: Advanced English level.

Why choose us?

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• You’ll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions. 
• You’ll be part of a truly diverse cross-cultural team and can have real business impact. 
• Flexible working policies, including up to 50% remote work. 
• Private medical care, life and health insurance, and gender-neutral paid parental leave 
• Colombia is one of Sanofi’s key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation. 
• Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants. 

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! 

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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!