CSV Specialist

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 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

Benefits

What We Offer

• Opportunities for learning, development, and professional growth.
• A collaborative and supportive work environment.
• The opportunity to work with industry-leading clients on impactful projects.

Your information will be kept confidential according to EEO guidelines.