CSV Validation Specialist – Pharma & Medical Devices

QRC Group, Inc; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QRC Group, LLC in Puerto Rico seeks an experienced CSV consultant to support installation and qualification of solid dosage equipment, including encapsulators, compression machines, hardness testers and related systems. Responsibilities include FAT to IOQ progression, on-site qualification activities, development of SOPs, calibration records and documentation controls, and ensuring GxP compliance.

Requirements: BS in Science, 5 years in regulated CSV, MS Office skills, excellent writing, and

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.

Responsibilities

• Verify equipment installed and configured at vendor site (FAT).
• Implement progression from FAT through IOQ per CC strategy.
• Install at manufacturing room for qualification activities.
• Conduct qualification activities in manufacturing room areas.
• Develop Standard Operating Procedures (SOPs).
• Generate and route calibration and preventive maintenance forms.
• Develop and approve GxP and automation impact assessments.
• Propose solutions to documentation issues and establish project documentation controls.
• Ensure activities meet or exceed regulatory requirements.

Skills

MS Office

Technical writing

Bilingual ENG/ES

Education

Bachelor in Science

Tools

MS Word

MS Excel

MS Project

Job description

QRC Group, LLC in Puerto Rico seeks an experienced CSV consultant to support installation and qualification of solid dosage equipment, including encapsulators, compression machines, hardness testers and related systems. Responsibilities include FAT to IOQ progression, on-site qualification activities, development of SOPs, calibration records and documentation controls, and ensuring GxP compliance.

Requirements: BS in Science, 5 years in regulated CSV, MS Office skills, excellent writing, and