Gerente De Aseguramiento De La Calidad - Cumplimiento

Catalent

Loma Hermosa, Buenos Aires, Argentina
**
Lead internal and external gxp audits
Manage capa and quality control systems
Oversee process validation and data integrity
** Catalent is seeking a Quality Assurance Manager in Compliance for its Loma Hermosa facility in Buenos Aires. The role involves leading quality audits, managing quality systems, and ensuring regulatory compliance in the pharmaceutical industry. **

Job Summary

  • The role involves leading and managing internal, corporate, and external audits with a significant impact on GxP compliance.
  • Candidates will be responsible for administering quality systems including CAPA, documentation, and training programs while ensuring regulatory alignment.
  • Catalent is a global leader in drug development offering opportunities to advance life-saving medicines from early development to market.

Matching Summary

Match Score: 75

** Catalent is seeking a Quality Assurance Manager in Compliance for its Loma Hermosa facility in Buenos Aires. The role involves leading quality audits, managing quality systems, and ensuring regulatory compliance in the pharmaceutical industry. **

Skills & Requirements

Must-have

  • Lead internal and external GxP audits
  • Manage CAPA and Quality Control systems
  • Oversee process validation and data integrity
  • Ensure compliance with cGMP and 21 CFR regulations

Nice-to-have

  • Strong leadership and team development skills
  • Strategic budget management capabilities
  • Effective cross-functional communication

Key Requirements

  • Professional degree in Pharmacy, Biochemistry, or Chemistry
  • Minimum 10 years of pharmaceutical industry experience
  • At least 5 years in Quality leadership positions
  • Advanced English reading and writing proficiency
  • Solid knowledge of ICH, USP, BP, and EP standards

Work Rights

Not specified

Tailored Resume

Cover Letter