Job title: Regional Qualification Senior Specialist
- Location: Bogotá, Colombia
About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Regional Qualification Manager within our M&S Services Bogota Hub, will be 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.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
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: At least 2 years of experience in data analytics or qualitications-validations within validation departments in the pharmaceutical sector, medical devices, biotechnology. Experience in equipment qualification documentation management (VMP/VP, URS, IQ, OQ, PQ). Experience working with Quality systems (Veeva, Kneat), Word, Excel, Power Point & Data analytics.
- Soft and technical skills: Experience in protocols and validation reports. Proficient in attention to detail, Time management, Written communication, Teamwork and collaboration, Adaptability, Accountability, analytical thinking.
- Education: Bachelor's degree (preferably in pharmacy, engineering, chemistry, biology, or related field.
- Languages: Advance English level is required.
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!
#LI-LAT
#LI-HYBRID
null