Risk & Compliance - ERP/SAP Validation and Qualification

Role Overview: At Takeda's Innovation Capability Center in Bengaluru, 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 validation and testing activities using modern tools and methodologies. As the Validation Lead, you will play a crucial role in delivering high-quality, compliant solutions that contribute to Takeda's mission of global impact and improvement. Key Responsibilities: - Lead all aspects of the qualification and validation deliverables of SAP ERP systems to ensure compliance with industry standards and regulatory requirements. - Create and implement detailed validation plans for SAP implementations, aligning with project timelines and deliverables. - Guide and mentor validation team members to develop their expertise and ensure successful project delivery in adherence to Takeda's compliance standards. - Collaborate with business and technology leaders to communicate validation risks and ensure a clear understanding of their impact and required actions. - Participate in testing activities such as test planning, test creation, test automation, test execution, defect reporting, and test closure for SAP-ECC, S4 HANA Migration, and implementation Projects. 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 roll up one's sleeves to get the job done. Additional Details: Takeda is committed to fostering an inclusive and collaborative workplace where individuals are valued for their backgrounds and abilities. Joining the ICC in Bengaluru will provide you with access to high-end technology, continuous training, and a diverse network of colleagues who will support your career growth. The company offers competitive compensation, a flexible work environment, comprehensive healthcare insurance plans, and various learning platforms to support your professional development.,