Freelancer CSV Compliance Analyst

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a CSV Compliance Analyst - SAP S/4 HANA on Freelancing Role for long time support to our projects in Chicago, IL.

You will be responsible for:

• Software Quality Assurance with Review and Approval Experience for SLC Deliverables
• Experience should have earlier in career in SDLC/Software Validation with writing and execution of SDLC deliverables (e.g. MVP testing)
• Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release).
• 5+ years of SQA experience with Review and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification)
• SAP Systems implementation
• Support as compliance analyst in the Review and Approval and implementation of regulated / non regulated IT applications.
• Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.
• Should have knowledge and experience of applying CSA approach in projects.

About you:

• Strong Validation Resource with 5+ yrs Experience
• Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.
• Previous experience with automated testing and implementation.
• Strong knowledge and experience around ERP Systems (SAP S/4 HANA, D365, etc)
• Proficient in understanding of GxP regulations and validation principles
• Good experience in Review of CAPA's, Change Control and Defects as it applies to Software Validation
• Familiarity with a range of applications/tools including JIRA, Confluence, Client-ALM, Tosca, Confluence, Veera ,Qtest, M-Files, or other continuous integration tools
• Authorized to work in the United States for any employer or proper documentation if associated with a third-party agency
• Must pass background and reference checks

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal.

Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.