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CSV Specialist

CSV Specialist

QRC Group, LLCVega Baja, PR, pr
Hace 19 días
Tipo de contrato
  • Quick Apply
Descripción del trabajo

Job Description

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.
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    Specialist • Vega Baja, PR, pr

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