What are the responsibilities and job description for the CSV Specialist position at PQE Group?
About the job
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 Consultant with 2 years of experience with in the lifescience / Biotech industry fitting the following mandatory skill-set and willing to work in Libertyville / Chicago / Kankakee, Illinois, US.
You will be responsible for :
- Manage CSV deliverables (creation / update) for remediating the lab systems
- Author / Review CSV Deliverables : Validation Plan, Initial System Assessment, Functional / User specifications, Functional risk assessment, design documents, SOP Planning, Data Integrity Assessment, traceability Matrix, protocols (IQ, OQ, and PQ), interim memo / release, and Validation summary report as per client procedure
- Execute Tests for Lab Systems / Manufacturing sytems
- Ensure all project-related risks are well managed and deliverables are validated (for GxP) / tested (for non-GxP) in accordance to SOP and the associated CSV requirements as per client procedure
- Prepare and maintain project plan tracking all the resources working on the project, and the progress of CSV activities.
About you :
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.
