Job title: Regional Qualification Expert
- 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 Expert 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:
- Conduct initial data interpretation and verify report accuracy against acceptance criteria
- Define statistical methods for data analysis and ensure adherence to protocols
- Utilize statistical tools to generate data graphs and interpret results
- Collaborate with site-specific Subject Matter Experts (SMEs) to review and discuss analysis outcomes
- Identify and report deviations, assessing their impact on qualification outcomes
- Summarize findings and provide clear interpretations of statistical analysis
- Ensure all reports comply with global and local quality regulations and standards
- Write a comprehensive report using the provided templates for QMS (Quality Management System)
About you
- Experience: At least 3 years of experience in data analytics or qualifications validations within validation departments in the pharmaceutical sector, medical devices, and /or biotechnology.
- Soft and technical skills: Stakeholder management, advanced communication skills (written and verbal). Decision making capabilities, proactive problem identification, conflict resolution, ability to work under pressure, presentation skills. Experience with Quality systems (Veeva, Kneat), Word, Excel, Power-Point & Data Analytics and process validations: protocols and validation reports.
- Education: Bachelor's degree in pharmacy (preferably), engineering, chemistry, biology, or related field.
- Languages: Advanced English level is MUST.
Why choose us?
- Our people are responsible for managing their career. Sanofi posts all non-executive opportunities for our people.
- We give priority to internal candidates.
- Managers provide constructive feedback to all internal interviewed candidates.
- We embrace diversity to hire best talent.
- We expect managers to encourage career moves across the whole organization.
- A few practical tips:
- Be sure to regularly update your Workday profile to simplify the application process.
- Be aware of any applicable eligibility criteria in the country to which you are applying.
- Before applying, inform your manager so they may support your career development goals.
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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