CSV Specialist
CSV Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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.
Qualifications :
- 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
Yes
Employment Type :
Contract
Employment Type
Remote
Company Industry
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
