IT Analyst
7500 - 9500 SGDANTER RECRUITMENT PTE. LTD.
We are seeking an experienced IT Analyst with expertise in SAP, MES, or Computer System Validation (CSV) to join pharma project delivery team. In this role, you will play a critical part in implementing, validating, and optimizing enterprise IT/OT systems within regulated pharmaceutical manufacturing environments.
Whether your background is rooted in ERP integration, shop-floor MES execution, or GxP quality and compliance, you will work closely with cross-functional teams to ensure seamless project execution that meets stringent regulatory standards (FDA, EMA, HAS).
Key Responsibilities
- Lead or support the implementation, upgrade, and optimization of enterprise applications (SAP, MES, or related manufacturing IT systems) for pharmaceutical clients.
- Prepare, execute, and review validation lifecycle documentation (UARS, FS, DQ, IQ, OQ, PQ, VSR) in accordance with GAMP 5, 21 CFR Part 11, and Annex 11 guidelines.
- Partner with business stakeholders to translate manufacturing, supply chain, or operational requirements into functional IT solutions.
- Ensure all systems comply with GxP regulations and strict Data Integrity standards throughout the project lifecycle.
- Coordinate between business end-users, IT/OT vendors, quality assurance, and project management teams to deliver projects on time and within budget.
Job Requirements
- Minimum 5 years of hands-on experience in one or more of the following core areas within the Pharmaceutical, Life Sciences or Manufacturing sector or projects.
- Functional/technical expertise in relevant SAP modules (e.g., SAP QM, MM, PP-PI, PM, or S/4HANA implementation).
- Hands-on experience with Manufacturing Execution Systems (e.g., Werum PAS-X, Syncade, Rockwell, or Siemens Opcenter).
- Deep experience leading Computer System Validation, lifecycle documentation, and GxP compliance.
- Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, EU Annex 11, and GxP regulatory requirements.
- Bachelor’s degree in Computer Science, Information Technology, Engineering, Pharmacy, or a related discipline.
- Excellent analytical, problem-solving, and cross-functional communication skills.
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