Risk & Compliance - ERP/SAP Validation and Qualification

Role Overview: As a Validation Lead at Takeda's Innovation Capability Center, you will be responsible for overseeing computer systems validation programs within a regulated cGMP environment. Your role involves collaborating with cross-functional teams to ensure compliance with industry standards and regulatory requirements, implementing risk-based validation strategies, and guiding the validation and testing activities using modern tools and methodologies. By delivering high-quality and compliant solutions, you will contribute to Takeda's mission and support the development of validation team members to achieve departmental goals. Key Responsibilities: - Lead all aspects of the qualification and validation deliverables of SAP ERP systems to ensure they meet industry standards and regulatory requirements. - Create and implement detailed validation plans for SAP implementations, aligning with project timelines and deliverables. - Collaborate with ERP projects and product teams, Quality Assurance, and business collaborators to define validation requirements, ensuring comprehensive testing and compliance. - Manage and lead Computer Systems Validation projects within Takeda DD&T, ensuring compliance with regulatory requirements. - Implement risk-based computer system validation methodology with a focus on risk identification, assessment, and mitigation controls. - Guide team members on best practices related to good documentation procedures for cGMP and other regulatory requirements. - Participate in project teams to create, review, and manage validation documents, oversee the execution of validation plans, and ensure regulatory compliance. - Proficient in project assessment, estimation, and full-cycle project management in JIRA, including story creation to closure. - Collaborate with the project PM and validation Managers to implement SAP-ERP test strategies and methodologies for functional and non-functional test automation. - Automate test cases using relevant frameworks and tools. - Coach, train, develop, motivate, and evaluate Validation team members to enhance their capabilities and achieve departmental priorities. Qualifications: - Experience: 8-10 years of experience in pharmaceutical validation of software applications, quality assurance, cGMP manufacturing. - Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment. - Education: Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences). - Strong understanding of Agile methodologies. - Excellent communication, presentation, and leadership skills. - Strong problem-solving skills and willingness to collaborate with cross-functional teams in a matrix organization. Additional Details: At Takeda's Innovation Capability Center in Bengaluru, you will have access to high-end technology, continuous training, and a diverse and inclusive network of colleagues to support your career growth. Takeda offers competitive compensation, a flexible work environment, comprehensive healthcare insurance plans, various learning platforms, diversity, equity, and inclusion programs, reimbursements, and different leave policies to support your personal and professional well-being.,