SAP Validation Expert

4 days ago

Makati City, National Capital Region, Philippines beBeeValidation Full time ₱2,500,000 - ₱3,000,000
Job Description

The SAP Validation Consultant is responsible for ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV), lifecycle procedures, manufacturing execution systems (MES), and data integrity requirements specifically for SAP.

This includes preparing validation plans, specifications, and qualification documentation to meet customer needs and regulatory requirements. The consultant will provide project milestones and reporting.

Key Responsibilities:
  • Prepare and execute testing activities – IQ, OQ, PQ including deviation handling and supported reporting.
  • Proactively fulfill the role as Consultant in small to medium complex Life Sciences IT projects.
  • Independently author or review validation deliverables for SAP S/4HANA validation.
Duties and Responsibilities
  • Assist the Project/Program Manager, the Project Validation Lead, Quality Project Lead or Project Validation Manager with quality and risk management issues. Conduct risk management assessments/workshops, and provide input to validation and test strategies.
  • Contribute to quality activities for Computer System Validation (CSV) projects/activities (including areas related to Data Integrity/ER).
  • Participate in small to medium complex E-2-E Validations.
  • Review projects and operations documentation to ensure process requirements are met according to the controlling QMS.
Required Skills and Qualifications

Minimum 3 years of experience performing end-to-end CSV activities for SAP S/4HANA required.

  • Strong understanding of core SAP modules (MM, PP, QM, PM, EWM and SD)
  • Strong understanding of validation processes including creation of deliverables and execution of protocols.
  • Good understanding of 21 CFR Part 11, EU Annex 11 and regulatory requirements.
  • Good knowledge of most phases of the V-model/Agile delivery methodology, and ISPE GAMP5 guidelines.
  • Life Sciences, biotech or pharmaceutical experience.
Benefits

Excellent organizational skills with strong attention to detail and accuracy.

Ability to work independently and with teams at various levels in the organization.

Ability to work in a very dynamic environment with clear sense of urgency.

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