Remote CSV Consultant

Job Opening for Remote CSV Consultant, Remote
We are currently working on below mentioned job opening i.e Job Opening for Remote CSV Consultant, Remote. Please let me know if you are interested in applying for the same.

6 month contract

Project description:  Our client is looking for a Sr. CSV Consultant to help with ongoing support for current/upcoming projects

You will work closely with Lab Systems team, IT, Validation, and business owners throughout the company by mainly providing CSV oversight. You will report directly into the Director of CSV.
The CSV team supports QC Lab Instrumentation in a 21 CFR 11, GMP/GLP/GxP environment
Majority of systems are validated, so majority of you the support is QA CSV oversight and handling technical reviews prior to QAV final approvals.
 Consultants day to day responsibilities:

Daily you will be working with Lab Systems group, IT, and Validation
Reviewing, editing, and approving SOP’s
Conducting risk assessments in GMP/GLP CFR 21 Part 11 and using the GAMP 5 approach
Generate and review test protocols on previously validated system changes/maintenance by following SDLC to ensure testing is completed per policies and SOPs
Handle technical review of executed systems and submit to QA Validation for final approval
You will also be tasked with working with business owners throughout the company
Walking thru a user manual or SOP with someone and gathering requirements based of off the business needs.
Required skills:

Experience in Biotech or Pharma
Prior experience doing end to end computer system validation (QMS, LIMs, supply chain, LMS)
Don’t need to have been a lead during the project, but was involved with each step of the validation process
Must have prior experience working with business owners
Extracting and gathering requirements
Demonstrated working knowledge of GAMP 5, “A Risk-Based Approach to Compliant GxP Computerized Systems”
Equipment Validation Engineer

Job Opening for Remote CSV Consultant, Remote
We are currently working on below mentioned job opening i.e Job Opening for Remote CSV Consultant, Remote. Please let me know if you are interested in applying for the same.

6 month contract

Project description:  Our client is looking for a Sr. CSV Consultant to help with ongoing support for current/upcoming projects

You will work closely with Lab Systems team, IT, Validation, and business owners throughout the company by mainly providing CSV oversight. You will report directly into the Director of CSV.
The CSV team supports QC Lab Instrumentation in a 21 CFR 11, GMP/GLP/GxP environment
Majority of systems are validated, so majority of you the support is QA CSV oversight and handling technical reviews prior to QAV final approvals.
 Consultants day to day responsibilities:

Daily you will be working with Lab Systems group, IT, and Validation
Reviewing, editing, and approving SOP’s
Conducting risk assessments in GMP/GLP CFR 21 Part 11 and using the GAMP 5 approach
Generate and review test protocols on previously validated system changes/maintenance by following SDLC to ensure testing is completed per policies and SOPs
Handle technical review of executed systems and submit to QA Validation for final approval
You will also be tasked with working with business owners throughout the company
Walking thru a user manual or SOP with someone and gathering requirements based of off the business needs.
Required skills:

Experience in Biotech or Pharma
Prior experience doing end to end computer system validation (QMS, LIMs, supply chain, LMS)
Don’t need to have been a lead during the project, but was involved with each step of the validation process
Must have prior experience working with business owners
Extracting and gathering requirements
Demonstrated working knowledge of GAMP 5, “A Risk-Based Approach to Compliant GxP Computerized Systems”
Equipment Validation Engineer