CSV Bioprocess Validation

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 to provide services of commissioning, equipment qualification (IOQ), computer system validation (CSV), Qualification Plan Develop & Approval and traceability matrix develop up to approval. 

Technical Skills:

• Experience in Tech Transfer, Process Design, Commissioning & Qualification.
• Vision system technologies (Strong).
• Inspection/packaging Concepts. 
• Development and Execution of Processes/Equipment Characterization
• Provides data analysis and interpretation and assesses 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.
• Experience in Automation process and/or Vision Inspection systems development.
• Knowledge in statistics using Minitab, JMP or other statistical software, project management skills and knowledge in development documentation protocols and reports.
   

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.
• 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.