SAP S/4HANA Consultant – PP/QM (Japanese Speaking/Pharmaceutical Industry)
Role Overview
We are seeking an experienced SAP S/4HANA Consultant specializing in Production Planning (PP) and Quality Management (QM) modules to support and enhance manufacturing and quality operations within a regulated pharmaceutical environment. The consultant will partner with manufacturing, quality assurance, supply chain, and validation teams to design, configure, and deliver compliant SAP solutions that align with GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements.
The ideal candidate brings hands-on S/4HANA experience, a strong understanding of pharma-specific processes (batch manufacturing, recipe management, electronic batch records, sampling, deviations, and stability studies), and the ability to translate business requirements into validated SAP configurations.
Key Responsibilities
SAP PP – Production Planning
- Configure and support S/4HANA PP processes including discrete, process, and repetitive manufacturing tailored to pharmaceutical batch and campaign production.
- Implement and maintain master data: Material Master, BOMs, Routings, Master Recipes, Production Versions, Resources, and Work Centers.
- Design and support MRP runs, demand management, planning strategies, capacity planning, and shop floor execution.
- Configure process orders, control recipes, PI sheets, and integration with MES / shop floor systems for batch execution.
- Support batch determination, batch derivation, shelf-life management, and serialization aligned with track-and-trace regulations (e.g., DSCSA, EU FMD).
- Troubleshoot order management, goods movements, backflushing, and confirmation issues in production.
SAP QM – Quality Management
- Configure and support QM processes across the pharma value chain: incoming inspection (raw materials, APIs), in-process quality checks, final release of finished goods, and stability studies.
- Set up inspection plans, inspection types, sampling procedures, master inspection characteristics (MICs), and quality info records.
- Implement Quality Notifications for deviations, complaints, CAPAs, and non-conformance handling.
- Configure Quality Certificates (Certificates of Analysis), batch release workflows, and usage decisions integrated with PP and MM.
- Support calibration management, vendor evaluation from a quality perspective, and integration with LIMS where applicable.
- Ensure electronic signatures and audit trails meet 21 CFR Part 11 and Annex 11 requirements.
Cross-Functional & Integration
- Manage end-to-end integration of PP/QM with MM, SD, WM/EWM, PM, and FICO modules.
- Collaborate with MES, LIMS, DMS, and serialization platform teams to ensure seamless data flow.
- Support cutover, data migration (LSMW, LTMC, Migration Cockpit), and hypercare activities.
Compliance & Validation
- Author and review GxP documentation: User Requirement Specifications (URS), Functional Specifications (FS), Configuration Specifications (CS), and Test Scripts (IQ/OQ/PQ).
- Participate in Computer System Validation (CSV) activities following GAMP 5 methodology.
- Support internal and external audits, including responses to FDA, EMA, and other regulatory inspections.
- Ensure all changes follow formal Change Control and Risk Assessment processes.
Project Delivery & Support
- Lead or contribute to full-cycle implementations, rollouts, upgrades, and AMS support engagements.
- Conduct workshops, gather requirements, perform fit-gap analysis, and prepare blueprint documents.
- Provide training, knowledge transfer, and post-go-live support to business users and key power users.
- Mentor junior consultants and contribute to internal knowledge bases and reusable assets.
Required Qualifications & Experience
- Proficient in both English and Japanese communication
- Experience: Minimum 5 years of hands-on SAP PP and QM consulting experience, with at least 1–2 full-cycle S/4HANA implementations.
- Industry: Demonstrated experience in pharmaceutical, biotech, or life sciences manufacturing (regulated GxP environment).
- Functional Expertise: Strong configuration and process knowledge in process manufacturing, batch management, master recipes, inspection planning, and quality notifications.
- S/4HANA: Proven experience with S/4HANA (on-premise or Private/Public Cloud), including knowledge of the Simplification List for PP/QM and Fiori applications.
- Compliance: Working knowledge of GxP, GMP, 21 CFR Part 11, EU Annex 11, GAMP 5, and CSV documentation standards.
- Integration: Hands-on experience integrating SAP with MES (e.g., SAP ME/MII, Werum PAS-X, Rockwell), LIMS (e.g., LabWare, LabVantage), and serialization solutions (e.g., SAP ATTP, Tracelink).
- Technical Skills: Familiarity with debugging ABAP, BAdIs, user exits, IDoc/EDI processing, and basic understanding of CDS views and Fiori app extensibility.
- Education: Bachelor's degree in Engineering, Computer Science, Pharmacy, Life Sciences, or related field.
- Certifications: SAP S/4HANA PP and/or QM certification strongly preferred.
Preferred / Nice-to-Have Skills
- Experience with SAP DMS (Document Management System) for controlled GMP documents.
- Knowledge of SAP EWM and serialization (SAP ATTP) for finished goods traceability.
- Exposure to SAP S/4HANA Manufacturing for Production Engineering and Operations (PEO).
- Experience with Solution Manager (ChaRM, test management) and ALM tools (HP ALM, Jira).
- Experience supporting global rollouts across multiple manufacturing sites and regulatory regions.
- Working knowledge of Lean / Six Sigma methodologies in pharma manufacturing.
Soft Skills & Competencies
- Strong analytical and problem-solving abilities with attention to detail — essential in a regulated environment.
- Excellent verbal and written communication skills; able to engage with both technical teams and business stakeholders.
- Ability to work independently, manage priorities, and deliver under tight project timelines.
- Collaborative mindset with the ability to operate effectively in cross-functional, multi-vendor teams.
- Commitment to compliance, quality, and continuous improvement.
Ho Chi Minh City
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