A nationwide pharmaceutical company is looking for a Senior GXP Systems Specialist to lead their team! This company manufactures sterile injectables for providers all over the country. Don't miss out on this great opportunity!
Job Description
- Report to GxP manager while working with GxP team, IT, and QA Compliance
- Manage all compliance issues with their project
- Support and coordinate with regulatory agencies
- Quality Programs: maintain, support procedure while ensuring cGMP expectations
- Create business procedures, enhancements, and continuity plans
- Collaborate with System Owner to develop Design Qualifications, User Requirements, Unit test scripts, UAT scripts, traceability matrix, IQ/OQ/PQ, and more
- Develop SOPs
- Validation/Part 11 assessments
Requirements
- Bachelors Degree and 5+ years of GxP CSV experience
- Understanding SDLC and CFR Part 11
- Technical Writing background
- Travel domestically and internationally