CSV Specialist

To support the installation of several manufacturing solid dosage equipment such as but not limited to:

• Encapsulator
  
• Checkweigher
  
• Compression machine
  
• Hardness tester
  
• Encapsulation machine
  
• Auxiliary equipment
  

Main activities should include:

• Verification of the equipment installed and configured at the vendor site (FAT).
  
• Implement the progression from FAT through IOQ in accordance with the CC strategy.
  
• Installation at the manufacturing room for qualification activities.
  
• Qualification activities in the manufacturing room areas.
  
• Development of Standard Operating Procedures.
  
• Generation and routing of calibration and preventive maintenance forms.
  
• Development and approval of GxP and automation impact assessments.
  
• Provide alternatives to resolve documentation situations.
  
• Establish project communication and documentation controls.
  
• Assure consistent quality of activities that meets or exceeds the requirements.
  

Requirements

• Bachelor in Science or related field
• 5 years of experience as CSV consultant in regulated industry.
• Experience with MS Office applications (Word, Excel and MS Project)
• Excellent technical writing skills.
• Bilingual: English and Spanish, speaking and writing.