CSV Specialist - job 1 of 3
Company Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!
Job Description
CSV Specialist with experience in Bioprocess Validations.
Technical Skills:
- Tech Transfer, Process Design, Commissioning & Qualification.
- Vision system technologies (Strong).
- Inspection/packaging Concepts.
- Development and Execution of Processes/Equipment Characterization
Duties:
- Provides data analysis/interpretation and assesses the impact of the data on the project.
- Establish Testing Strategies.
- Technical Reports Development.
- Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies.
Qualifications
- BS or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/Engineering or related discipline.
- Background in pharmaceutical products manufacturing environment and in manufacturing and laboratories areas
- More than five (5) years of experience working with process validation life cycle, experience in commissioning and validating laboratory and manufacturing computerized systems in a manufacturing environment, and training in validation methodologies, technologies, and process control computer systems.
- Knowledge on computerized system with data collection software (database).
- Strong knowledge of cGMP, GAMP, SAT, FDA, 21 CFR Part 11 and Data Integrity Regulations.
- Experience in Automation process and/or Vision Inspection systems development.
- Knowledge in statistics using Mini-tab, JMP or other statistical software, project management skills and knowledge in development documentation protocols and reports.
- Knowledge in MS Project Management and MS Vision programs.
- Advanced scientific analysis and troubleshooting skills.
- Experienced in Instrument Performance qualification, and method configuration
- Excellent skills writing commissioning/ validation, and technical documentation in English and using MS Office applications.
- Bilingual (both English/Spanish)
Additional Information
All your information will be kept confidential according to EEO guidelines.
Average salary estimate
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