## Mandatory Requirements (Must Have):
1. Education:
   - Bachelor's degree in Engineering, Chemistry, Sciences, or related field
   - Current certifications in cGMP and FDA regulations

2. Experience:
   - Minimum 5 years of experience in FDA-regulated pharmaceutical industry
   - Demonstrable experience in complex quality investigations
   - Solid experience in CAPA (Corrective Action and Preventive Action) management
   - Proven track record in responding to FDA audit findings

3. Technical Knowledge:
   - Mastery of Root Cause Analysis methodologies
   - Deep understanding of FDA regulations for pharmaceutical manufacturing
   - Solid knowledge of pharmaceutical quality systems

4. Skills:
   - Bilingual (Spanish and English) - oral and written
   - Advanced analytical capability for complex investigations
   - Excellent technical documentation skills

## Essential Requirements (Should Have):
1. Technical Experience:
   - Experience with electronic quality systems, preferably Veeva
   - Knowledge of quality metrics and KPIs
   - Experience in corrective actions management
   - Familiarity with pharmaceutical manufacturing processes

2. Professional Skills:
   - Ability to work independently
   - Effective presentation and communication skills
   - Experience in handling multiple simultaneous projects
   - Ability to interact with all levels of the organization

3. Knowledge:
   - Understanding of validation processes
   - Knowledge of statistical analysis tools
   - Familiarity with ICH guidelines

## Desired Requirements (Nice to Have):
1. Additional Experience:
   - Previous experience with Infinity system
   - Specific experience in solid and liquid drug manufacturing
   - Previous experience in similar pharmaceutical companies
   - Additional quality certifications (ASQ, Six Sigma)

2. Specialized Knowledge:
   - FDA audit experience
   - Knowledge of other electronic quality systems
   - Experience in personnel training
   - Familiarity with lean manufacturing

3. Additional Skills:
   - Continuous improvement experience
   - Knowledge of agile methodologies
   - Mentoring skills
   - Experience in organizational change management

4. Certifications:
   - Six Sigma Black Belt
   - Project Management Certification
   - Specific pharmaceutical industry certifications