CSV Specialist

QRC Group, Inc • Caguas, PR

3d

About The Position

CSV Specialist 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.

Requirements

• Bachelor in Science or related field
• 2-3 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

• 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.

What This Job Offers

• Career Level: Mid Level