CSV Specialist
QRC Group, Inc•Caguas, PR
1d
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
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.
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What This Job Offers
Career Level
Mid Level
