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.