Computer Validation Specialist

Vor 2 Tagen

Basel, Schweiz Roche Vollzeit

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

The “Site Network Basel/Kaiseraugst” organization, part of the global Group Function “Corporate Strategy, Sustainability & Sites”, provides the infrastructure and services for the entire site and develops these continuously and innovatively. We work with all stakeholders along the entire value chain, from early research to patient care. With us, you can look forward to a modern organizational model in which you can contribute your talents in meaningful work under your own responsibility. We guarantee creative freedom and freedom of choice in our organization. You won't find traditional superiors with us.

Within the “Site Network Basel/Kaiseraugst” organization, we design tailor-made solutions together with our stakeholders in the “Business Solutions” cluster. In the “Business Process Engineering” group, we ensure that the systems provided for “Logistic Solutions” are supported and further developed accordingly. In the role of “Business Validation Manager” and “Process Owner”, you ensure that the system/applications are operated in validated status.

Your Opportunity

The Process Owner (PO) works with the System Owner and Quality teams to release the system according to the current CSV regulations.

The Process Owner (PO) is accountable for ensuring the computerized system (CS) remains in a validated state and is fit for its intended use throughout its lifecycle. Key responsibilities include:

  • Ensuring the system meets regulatory and company requirements.
  • Ensuring the system is validated, according to an approved Validation Plan and the subsequent Validation Report.
  • Defining and operationalizing appropriate processes, SOPs, and qualifications/validation documents.
  • Identifying and mitigating system risks (e.g., quality, safety, business) and addressing residual system risks post-acceptance.
  • Overseeing changes, enhancements, and compliance with change management procedures.
  • Ensuring the investigation and resolution of incidents, reviewing system documentation, and ensuring access control procedures are followed.
  • Approving system lifecycle documents, risk assessments, and system-related documentation.
  • Maintaining data integrity of GxP records (ALCOA+).
  • Allocating resources for system development and operation, and ensuring appropriate staffing.
  • Acting as the primary contact during audits, responding to findings, and ensuring GxP compliance.

The Business Validation Lead (BVL) oversees and manages the validation activities for the computerized systems to ensure compliance with regulatory requirements, company policies, and industry best practices.

Ensure that all validation activities are conducted in compliance with applicable regulatory requirements (e.g., FDA, EMA) and company policies. Determine validation approach in collaboration with the IT Validation Manager in accordance with directives and guidelines. Liaise with Business Quality, Informatics Quality, IT Validation Lead, Process Owner, and System Owner to ensure compliance with corporate quality policies and standards. Coordinate the business organization to ensure that validation deliverables are provided in a timely manner according to the project schedule and R&R RACI. Create, review, and approve all validation-related documents. Ensure that objective evidence is aptly captured, including unit tests, SAT, UAT, and IV, and that requirements are traced to test cases. Ensure appropriate test execution and documentation. Support audit teams as a CSV Subject Matter Expert and assist with audit/inspection preparation. Support system maintenance to ensure a validated state and permanent audit readiness.

Who You Are
  • Possess knowledge and understanding of CSV (Computerised System Validation) and GxP regulations.
  • Experienced in working within highly regulated environments.
  • Demonstrate excellent collaboration and communication skills to foster a cooperative and productive team environment.
  • Exhibit confidence and resilience, enabling effective decision-making and leadership in challenging situations.
  • Required to have IT knowledge.
  • Recommended to have SAP knowledge.
  • Required to have expertise in project management and risk management.
  • Must be proficient in both spoken and written English and German.

Are you interested? Apply now

Who We Are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche's largest sites.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

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