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
.
- Positive 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
📌 Aspentech MES (Bengaluru)
🏢 UST
📍 Bengaluru