Onsite GMP QC Systems Consultant | CSV/Validation Lead

Stark Pharma Solutions Inc; Frankford (DE); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Stark Pharma Solutions Inc in Frankford, DE is seeking a GMP QC Systems Consultant for a 12+ month contract onsite. The ideal candidate will drive the implementation, integration, and validation of Quality Control laboratory systems in a regulated pharma setting.

The role requires 8+ years in GMP environments, hands-on CSV/CSA, GAMP5, IQ/OQ/PQ, and data migration. Collaboration with QA, IT, and laboratory teams is essential to ensure project success and regulatory compliance.

Qualifikationen

• 8+ years of experience in GMP-regulated environments (pharma/biotech).
• Experience implementing and validating QC laboratory systems.
• Strong CSV/CSA, GAMP5, IQ/OQ/PQ knowledge and risk-based validation approach.
• Cross-functional project coordination and data migration experience.

Aufgaben

• Lead implementation and integration of GMP QC laboratory systems.
• Coordinate configuration, data migration, deployment, and go-live activities.
• Manage project timelines, risks, budgets, and stakeholder communications.
• Support CSV/CSA activities including IQ/OQ/PQ execution and documentation.
• Perform risk assessments, testing, and validation per GAMP5 and GxP requirements.
• Collaborate with QA, IT, lab teams, vendors, and stakeholders for delivery.
• Ensure compliance with GxP and Data Integrity; prepare status reports.

Kenntnisse

GMP QC Systems

CSV/CSA

GxP validation

Project management

Stakeholder management

Communication

Risk assessment

Documentation

Ausbildung

Bachelor's degree in Life Sciences

Tools

LIMS

SDMS

Empower

LabX

QuantStudio

SoftMax Pro

Jobbeschreibung

Stark Pharma Solutions Inc in Frankford, DE is seeking a GMP QC Systems Consultant for a 12+ month contract onsite. The ideal candidate will drive the implementation, integration, and validation of Quality Control laboratory systems in a regulated pharma setting.

The role requires 8+ years in GMP environments, hands-on CSV/CSA, GAMP5, IQ/OQ/PQ, and data migration. Collaboration with QA, IT, and laboratory teams is essential to ensure project success and regulatory compliance.