This role involves reviewing and ensuring necessary validations such as aseptic simulations, process, and cleaning validations for manufactured products
Job Summary
This role involves reviewing and ensuring necessary validations such as aseptic simulations, process, and cleaning validations for manufactured products.
The company is committed to innovation with a patient-centered approach and values diversity, talent, and commitment in an inclusive environment.
The position includes responsibilities for managing quality events, CAPAs, change controls, documentation, and participating in internal, regulatory, and corporate audits.
Matching Summary
This role involves reviewing and ensuring necessary validations such as aseptic simulations, process, and cleaning validations for manufactured products.
Skills & Requirements
Must-have
Validation execution and management
Quality event and CAPA management
Internal and regulatory audit participation
Good Manufacturing Practices (GMP)
Quality documentation control
Aseptic manufacturing validation
Nice-to-have
Experience with biological and sterile product manufacturing
Project participation and transfer experience
Risk management and continuous improvement methodologies
Advanced English proficiency
Innovation and leadership mindset
Key Requirements
Bachelor’s degree in Health Sciences or Pharmacy
Relevant pharmaceutical industry experience
Knowledge of cleaning validation processes
Advanced Spanish and English language skills
Regulatory knowledge of GMP and applicable pharmacopeias
Experience with quality system tools including CAPAs and deviations