Jr. Csv Specialist

QRC Group

  • Vega Baja, PR
  • Permanente
  • Tiempo completo
  • Hace 12 días
*Jr. 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
  • 2-3 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.
Job Types: Full-time, ContractWork Location: In person

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