Job
Core
Support the planning, coordination, execution, and evaluation of process validation activities in accordance with GMP requirements to ensure manufacturing processes remain validated.
Role type
Process Validation Scientist
Builds
Validated manufacturing processes for pharmaceutical products
Domain
Pharmaceutical manufacturing / Process Validation
Required skills
Process validation protocols, GMP compliance, risk assessment, statistical data analysis, ERP systems, root cause analysis, CAPA implementation, regulatory guidelines knowledge, batch record review, manufacturing process monitoring
Preferred skills
Master's degree in relevant field, Greek language proficiency, experience with Minitab/JMP, familiarity with electronic document management systems
Technologies
ERP systems, Minitab, JMP, Microsoft Office
Responsibilities
Check weekly production schedule to determine validation needs; Review batch manufacturing records and documentation for validation studies; Conduct risk assessments and assist in responding to stakeholder questions; Perform speed-evaluation tests during compression and physical property testing; Update process validation database via ERP; Provide official reports proving compliance with acceptance criteria; Monitor processes under validation and evaluate analytical results; Prepare, review, and execute validation protocols and reports; Analyze process data to assess capability and control; Support investigations into deviations and OOS results; Ensure compliance with GMP and internal quality systems.
Seniority
Mid-level, hands-on IC
