CSV Specialist
QRC Group, LLC•Vega Costera, PR
About The Position
To support the installation of several manufacturing solid dosage equipment such as but not limited to: Encapsulator, Checkweigher, Compression machine, Hardness tester, Encapsulation machine, and Auxiliary equipment.
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.
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
Job Type
Full-time
Career Level
Senior
