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Skillspark AB
Technical Erp Implementation Specialist
Posted on Nov. 27, 2024
- København, Denmark
- 0 - 0 USD (yearly)
- Full Time
emagine is currently seeking a Technical ERP Implementation Specialist for one of our clients in the pharmaceutical industry.
Job Description
To support the implementation of an ERP solution for Local Manufacturing and Affiliate in Iran with go live in May 2025. Allocation, 100% from 9. December 2024 – June 2025.
This role involves working closely with an international team and the supplier to ensure configuration management, technical design documentation, and installation verification processes meet compliance and operational excellence standards.
Responsibilities include but are not limited to:
Configuration Management:
Create and maintain configurations item lists for each environment to ensure consistency and traceability throughout the project until go-live.
Together with the supplier establish and maintain change process for all system changes and configurations.
Collaborate with stakeholders to validate configurations meet business and compliance requirements.
Technical Design Documentation:
Together with the supplier ensure that technical design documents, including system architecture.
Ensure documentation adheres to GxP standards and supports validation processes.
Provide clear, concise, and maintainable documentation for technical and non-technical stakeholders.
Installation Verification:
Perform and document installation verification testing to confirm that systems are installed according to specifications.
Collaborate with Quality Assurance to ensure compliance with GxP requirements.
Troubleshoot and resolve issues identified during installation or validation processes.
Collaboration and Communication:
Work closely with project managers, quality assurance teams, and ERP vendors to ensure seamless integration and implementation.
Serve as a technical liaison between IT, business stakeholders, and external consultants.
Provide regular updates on technical progress, risks, and mitigation strategies to project leadership.
Compliance and Standards:
Adhere to GxP and regulatory requirements, ensuring that all deliverables meet industry and company standards.
Participate in audits and provide necessary documentation to demonstrate compliance.
Support validation activities, including system qualification and testing.
Preferred qualifications
GxP compliance training or certifications (e.g., Good Documentation Practices, GMP).
Experience in pharmaceutical, biotech, or life sciences industries.
Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field.
Proven experience in ERP implementation, preferably within a GxP-regulated environment.
Strong knowledge of configuration management principles and tools.
Experience with technical design documentation, including creating and maintaining system specifications.
Familiarity with installation verification processes and validation lifecycle in GxP environments.
Understanding of regulatory requirements such as FDA, EMA, and other relevant standards.
Proficiency in ERP platforms (e.g., SAP, Oracle, Microsoft Dynamics, etc.).
Strong analytical and problem-solving skills with a keen eye for detail.
Excellent written and verbal communication skills.
Start date: 09-12-2024
End date: 30-06-2025
Allocation: Full time, time & material
Location: Bagsværd, Denmark (onsite is required on Monday - Wednesday)
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