What are the responsibilities and job description for the CSV Resource - Minneapolis position at PQE Group?
We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998 . With more than 2000 employees, 45 nationalities and 40 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a multicultural and challenging company with many local and international projects, and colleagues from all over the world .
Due to a constant growth, we are looking for a Senior CSV Resource join our team and support upcoming projects in Minneapolis, MN.
Responsibilities include, but are not limited, to the following :
- SDLC / Software Validation with writing and execution of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release).
- Review and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification).
- Strong understanding of 21 CFR Part 11 regulations along with knowledge of other regulations (e.g. HIPAA, SOC 1 / 2, GDPR, PCIDSS, etc.)
- Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.
- Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.
- Role must maintain compliance expertise and be effective at applying requirements in the IT and business environment that supports business goals and maintaining a compliant state.
- Review of CAPA's, Change Control and Defects as it applies to Software Validation while concurrently having good soft skills such as a good and effective communicator and vocal during meeting and projects.
Our ideal candidate should have the following features :
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.
