CSV Consultant – GxP Validation & IOQ Expert

QRC Group; Vega Baja (PR); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

QRC Group in Vega Baja, Puerto Rico seeks a seasoned CSV consultant to support installation and qualification of manufacturing equipment in a regulated environment. You will verify FAT IOQ progression and help establish documentation controls onsite.

Requirements: Bachelor in Science or related field; 5 years’ CSV experience in a regulated industry; proficiency with MS Word, Excel and MS Project; excellent technical writing; and bilingual English/Spanish.

Qualifikationen

• Bachelor in Science or related field.
• 5 years of CSV consulting experience in regulated industry.
• Proficiency with MS Word, Excel, and MS Project.
• Excellent technical writing skills.

Aufgaben

• Verify installed equipment at vendor site (FAT).
• Implement progression from FAT through IOQ per CC strategy.
• Installation in manufacturing room for qualification activities.
• Qualification activities in manufacturing areas.
• Develop Standard Operating Procedures.
• Generate and route calibration and preventive maintenance forms.
• Develop and approve GxP and automation impact assessments.
• Provide alternatives to resolve documentation issues.
• Establish project communication and documentation controls.
• Assure consistent quality of activities that meet or exceed requirements.

Kenntnisse

Bilingual: English/Spanish

Technical writing

MS Office proficiency

Ausbildung

Bachelor in Science or related field

Tools

MS Word

MS Excel

MS Project

Jobbeschreibung

QRC Group in Vega Baja, Puerto Rico seeks a seasoned CSV consultant to support installation and qualification of manufacturing equipment in a regulated environment. You will verify FAT IOQ progression and help establish documentation controls onsite.

Requirements: Bachelor in Science or related field; 5 years’ CSV experience in a regulated industry; proficiency with MS Word, Excel and MS Project; excellent technical writing; and bilingual English/Spanish.