CSV Specialist
- QRC Group, LLC
- Vega Baja, Puerto Rico
- $83,200 – $114,400
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
- 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.
Skills
- Computer System Validation
- GxP
- FAT
- IQ/OQ
- Technical Writing
- MS Project
- Bilingual (English/Spanish)
