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Job Details

All Jobs / Req# NOVRJP00012047
Req Number:
NOVRJP00012047
Req Title:
Coordinator
Client:
A Major Pharma Company
Work Address:
Durham, NC
Req Release Date:
07/25/2024
Duration:
15 months
Hours a week:
40 Hours
Position Summary

Title: SAP Integration Specialists

Key Responsibilities:

  • Collaborate with Subject Matter Experts (SMEs) to assess the impact of a new SAP Implementation on current business practices, ensuring a seamless integration with existing workflows.
  • Update and maintain critical documentation, including Standard Operating Procedures (SOPs), Work Instructions, Master Batch Records (MBRs), and product specifications, to align with SAP implementation.
  • Work closely with SMEs to identify all impacted documents and establish work plans to update all documents within given project timelines, ensuring no disruption to ongoing operations.
  • Provide comprehensive support to end users during system testing and the go-live phase, addressing any issues promptly to minimize downtime.
  • Develop detailed training materials for end users, focusing on transitioning to SAP, and facilitate training sessions to ensure a smooth transition.

Additional Duties:

  • Contribute to the development of test cases and business scenario tests, ensuring thorough coverage of all SAP functionalities.
  • Review and update SOPs and Work Instructions to reflect changes required with SAP, maintaining compliance with regulatory standards.
  • Ensure compliance with the Client's standards for system-supported processes, upholding the company's commitment to quality and safety.
  • Develop role-based training and transition plans to help users adapt to the new system, fostering a culture of continuous learning and improvement.
  • Support the operational change control process, ensuring that all changes are documented and communicated effectively.
  • Train and expand the Super User community for operational support, building a network of knowledgeable users to assist their peers.
Qualifications:

Experience Required:

  • Minimum of 4 years in pharmaceutical manufacturing, with a strong understanding of GxP Documentation and regulatory requirements.
  • Proven experience using SAP in a regulated environment, demonstrating the ability to navigate and utilize the system effectively.
  • Experience in authoring SOPs, Work Instructions, and Training materials, showcasing strong writing and communication skills.
  • Hands-on experience performing system testing in a validated environment, with a keen eye for detail and a commitment to accuracy.

Preferred Qualifications:

  • Bachelor's degree in Supply Chain Management, Business Administration, or a related field.
  • Excellent interpersonal skills, with the ability to work collaboratively with a diverse team and communicate effectively at all levels of the organization.
  • This job description aims to provide a comprehensive overview of the role, highlighting the importance of SAP expertise in optimizing supply chain operations and ensuring regulatory compliance. The ideal candidate will be a proactive, detail-oriented professional with a passion for technology and continuous improvement.
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