Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization that delivers a diverse portfolio of medicines essential to our patients around the world
Job Summary
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization that delivers a diverse portfolio of medicines essential to our patients around the world.
The QA Associate’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
Matching Summary
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization that delivers a diverse portfolio of medicines essential to our patients around the world.
Skills & Requirements
Must-have
GMP manufacturing experience
Quality oversight of contract manufacturers
Regulatory inspection preparation
Batch release compliance
Deviation and change control management
cGMP and regulatory compliance
Nice-to-have
Coaching and mentoring skills
Root cause analysis experience
Statistical skills application
Strong written and verbal communication
Interpersonal and networking skills
Ability to organize and prioritize tasks
Influence and relationship management
Key Requirements
BS in Pharmacy, Chemistry, or Life Sciences
Minimum 5 years GMP QA floor support experience
Minimum 10 years QA experience in big pharma
Foundational knowledge of ICH and EMA regulations
Process Validation and Technical Transfer experience