UST
Website:
ussmokeless.com
Company:
https://www.linkedin.com/company/ustglobal
Industries: IT Services and IT Consulting
Job details:
Role Description
JD: Required Skills & Experience
- Strong hands-on experience in MES, preferably AspenTech MES.
- Strong practical knowledge of GxP requirements and regulated life sciences/pharmaceutical environments.
- Proven experience in preparing and maintaining GxP/CSV/CSA and qualification documentation.
- Good understanding of MES validation and qualification lifecycle.
- Experience with IQ/OQ/PQ, URS, functional/design specifications, risk assessments, traceability, and validation protocols/reports.
- Strong understanding of data integrity principles and GxP compliance.
- Excellent documentation, communication, stakeholder management, and analytical skills.
- Ability to work independently and collaborate effectively with cross-functional teams. Preferred
- Experience working with pharmaceutical manufacturing or other highly regulated GxP environments.
- Experience supporting GxP audits/inspections and remediation activities.
- Familiarity with computerized system validation (CSV) / computer software assurance (CSA) practices.
Skills
AspenTech MES, GxP, Manufacturing Execution Systems
Click on Apply to know more.
