Qualification Specialist

Qualification Specialist

Location: Woodside, CA Duration: 6 months

As Qualification Specialist in the Equipment Integration team, you are responsible for caring about the GMP requirements. The team is responsible for transferring existing Lab Equipment from Spark Network to Roche Connect Network (RCN). Including replacing the HW, OS and renewing the application including the configuration and data. Your work requires you to actively interface with equipment owners, product/project managers, and business stakeholders to design and develop the build, release, and deploy for digital solutions. Responsibilities involve ensuring that our digital solutions meet regulatory requirements and quality standards, including qualified equipment, partially connected to validated software, and processes to ensure they perform as intended and comply with regulations. Excellent communication skills and teamwork are a must.

Responsibilities:

• Qualification Strategy: Develop and implement a qualification strategy 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 that will be connected to RCN including their interfaces and automation applications. Ensure that all qualification activities are properly documented and executed according to established procedures.
• Risk Assessment: Conduct risk assessments to identify potential risks associated with the use of digital solutions in a GMP environment. Develop risk mitigation strategies and ensure that 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. This includes executing test cases, analyzing results, and documenting findings.
• Compliance and Documentation: Ensure that all qualification activities are compliant 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 the latest industry trends and regulatory requirements in the field of validation.
• Communication and stakeholder management: Act as an interface between business and IT functionals and as a contact point for business leads in order to launch initiatives, leading and driving the scoping phase.

Candidate requirements:

• Understanding of lab systems lifecycle models and experience with business/end-user applications.
• Strong knowledge in qualification principles and practices in a GMP environment.
• Experience in qualification of digital solutions, including Release Management processes and controls.
• Experience in managing infrastructure through multiple product releases, and have passion for reliability and security.
• Work with management to set priorities, track operational metrics.
• Demonstrate knowledge of current GxP requirements and documentation standards with the ability to write validation docs.
• Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus.
• Displays skills and capabilities in the area of business partnering and/or product management.
• Proactively lead the validation efforts throughout the E2E process and work in a cross-functional and global team.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy and able to explain complex concepts with clarity and simplicity.
• Demonstrates ability to identify, troubleshoot and resolve issues quickly and effectively.
• Positive attitude and high energy with exceptional cross-group collaboration working with partner teams
• Possess a combination of analytical thinking, hands-on problem-solving, and a customer-service mindset
• Excellent communication skills - fluent in written and spoken English.