Qualification Specialist � Equipment Integration

As a Qualification Specialist in the Equipment Integration team, you are responsible for ensuring compliance with GMP requirements. The team is responsible for transferring existing Lab Equipment from the Spark Network to the Roche Connect Network (RCN), including replacing the hardware, operating system, and renewing the application with updated configuration and data.

Your work requires you to actively interface with equipment owners, product/project managers, and business stakeholders to design and develop build, release, and deployment processes for digital solutions. Responsibilities involve ensuring that digital solutions meet regulatory requirements and quality standards, including qualified equipment partially connected to validated software, ensuring they perform as intended and comply with regulations. Excellent communication skills and teamwork are essential.

Responsibilities

• Qualification Strategy: Develop and implement qualification strategies for digital equipment, ensuring alignment with regulatory requirements, industry best practices, and Roche's internal standards.
• Qualification Plans and Protocols: Create qualification plans and protocols for equipment connected to RCN, including interfaces and automation applications. Ensure all qualification activities are properly documented and executed according to established procedures.
• Risk Assessment: Conduct risk assessments to identify potential risks associated with digital solutions in a GMP environment. Develop risk mitigation strategies and ensure appropriate controls are in place.
• Testing and Qualification: Collaborate with cross-functional teams to perform testing and qualification activities for digital solutions, particularly with QA SMEs. Execute test cases, analyze results, and document findings.
• Compliance and Documentation: Ensure all qualification activities comply with relevant regulatory requirements such as GMP and data integrity guidelines. Maintain accurate and up-to-date validation documentation, including validation plans, protocols, reports, and change control documentation.
• Continuous Improvement: Drive continuous improvement initiatives related to qualification processes, tools, and methodologies. Stay updated with industry trends and regulatory requirements in validation.
• Communication and Stakeholder Management: Act as an interface between business and IT teams, serving as a key contact point for business leads to launch initiatives, lead, and drive the scoping phase.
  
  

Requirements

• Strong understanding of lab systems lifecycle models and experience with business/end-user applications.
• In-depth knowledge of qualification principles and practices in a GMP environment.
• Hands-on experience in qualification of digital solutions, including release management processes and controls.
• Proven experience in managing infrastructure across multiple product releases with a passion for reliability and compliance.