Need SAP GMP Consultant

Need SAP GMP Consultant

Onsite Chicago IL

Suitable candidate will get an interview.

Long term contract.

Local preferred.

Job Summary

We are seeking an experienced SAP GMP Consultant with strong expertise in SAP solutions within regulated pharmaceutical, biotechnology, or life sciences environments. The ideal candidate should possess in-depth knowledge of GMP compliance, SAP validation processes, and quality management requirements.

Required Skills

Strong experience in SAP GMP-compliant environments.

Hands-on experience with SAP modules such as:

• SAP QM (Quality Management)
• SAP PP-PI (Production Planning for Process Industries)
• SAP MM (Materials Management)
• SAP EWM/WM (Warehouse Management) preferred.

• Experience with Computer System Validation (CSV) and GxP regulations.
• Knowledge of FDA 21 CFR Part 11, EU GMP, and Annex 11 compliance requirements.
• Experience in SAP documentation, SOPs, validation protocols, and audit support.
• Understanding of pharmaceutical manufacturing and quality processes.
• Experience in SAP S/4HANA environments is preferred.

Responsibilities

• Configure and support SAP solutions in GMP-regulated environments.
• Ensure SAP processes comply with GMP and regulatory requirements.
• Prepare and maintain validation documentation (URS, FS, DS, IQ, OQ, PQ).
• Support internal and external audits.
• Collaborate with business stakeholders to gather requirements and implement solutions.
• Participate in system upgrades, testing, and change management activities.