CSV Specialist

  • Contract

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

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.

Qualifications

  • 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.