CSV Specialist

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

Job Description

To support the installation of several manufacturing solid dosage equipment such as but not limited to:

• Encapsulator
• 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.