CSV Specialist at QRC Group Inc
Vega Baja, Puerto Rico, USA -
Full Time


Start Date

Immediate

Expiry Date

01 Nov, 25

Salary

0.0

Posted On

03 Aug, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Writing, Regulated Industry, Ms Project, English, Spanish

Industry

Information Technology/IT

Description

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

o 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

Responsibilities

Please refer the Job description for details

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