Job Description
Core Skills:
- Strong cross-functional troubleshooting, communication, and negotiation skills
- Master’s or Ph.D. in Science/Engineering
- Experience in cGMP investigations within pharmaceutical manufacturing (OSD preferred)
Key Responsibilities
- Lead/develop cGMP investigations for OSD manufacturing deviations, nonconformances, and atypical events
- Perform root cause analysis using tools like 5-Why, Fishbone, and Fault Tree
- Review manufacturing, engineering, and QC data (MES, LIMS, SCADA, historian tools, batch records, etc.)
- Coordinate with QA, QC, Engineering, and Operations for event triage, containment, CAPA, and batch disposition
- Author investigation reports, CAPAs, product impact assessments, and support audit readiness
Preferred Experience
- OSD processes: blending, granulation, compression, coating, encapsulation
- eQMS, MES, LIMS, deviation/CAPA systems, trending tools, AI tools
- OOS/OOT investigations, GDP documentation, data integrity, and pharmaceutical quality systems
Key Traits
Strong analytical/problem-solving skills, ability to manage multiple investigations, interpret manufacturing/lab data, and proactively drive resolutions in cross-functional environments.