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 http://www.**qrcgroup.com**/ to learn more about our services and solutions!

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.

• 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.

All your information will be kept confidential according to EEO guidelines.