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 general and local quality regulations and standards
- Write a comprehensive report using the provided templates for QMS (Quality Management System)
About you
- Experience: At least 5 years of experience in data analytics or qualifications validations within validation departments in the pharmaceutical sector, medical devices, and /or biotechnology.
- Soft and technical ski