Risk and Compliance, Analyst Validation COE

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Job Description

The Future Begins Here

At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet.

Bengaluru, the city, which is India’s epicenter of Innovation, has been selected to be home to Takeda’s recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.  

At Takeda’s ICC we Unite in Diversity

Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team.

About the role:

The Risk and Compliance, Analyst is responsible for overseeing computer systems validation programs across the organization within a regulated cGMP environment. This individual collaborates with cross-functional teams to ensure compliance with industry standards and regulatory requirements, implements risk-based validation strategies, and oversees validation and testing activities using modern tools and methodologies. This role supports Takeda's mission by delivering high-quality, compliant solutions while guiding and developing validation team members to achieve departmental goals.

How you will contribute:

• Support the planning, drafting, and maintenance of validation documentation for Computerized systems in accordance with regulatory requirements.
• Assist in developing and executing testing protocols such as DQ, IQ, OQ, and PQ to ensure systems function as intended.
• Perform risk analysis activities, identify potential issues, and help implement mitigation strategies for IT, lab, and manufacturing systems.
• Collaborate with cross-functional teams and external vendors during system implementation to align on validation and quality standards.
• Maintain up-to-date and accurate validation records, ensuring compliance with industry best practices and regulatory expectations.
• Use modern quality tools (e.g., JIRA, Confluence, Qtest) and work effectively in agile environments to support efficient project execution.
• Contribute to the investigation and resolution of deviations or non-conformances encountered during validation activities.
• Stay updated with current industry regulations, guidelines, and emerging trends to enhance validation processes and support ongoing compliance.

Skills and qualifications:

• 3-4 years of experience in computer system validation or a similar role within regulated industries.
• Solid understanding of GxP regulations and industry standards (e.g., FDA, EMA) relevant to manufacturing IT systems.
• Hands-on experience with Computerized system validation documentation practices.
• Familiarity with modern quality and project management tools such as JIRA, Confluence, and Qtest.
• Proficient in developing and executing validation testing protocols (DQ, IQ, OQ, PQ) for computerized systems.
• Strong risk assessment skills, with the ability to identify, analyze, and mitigate validation-related risks.
• Effective communicator with strong written and verbal skills, able to work collaboratively within cross-functional and global teams.
• Demonstrated problem-solving, analytical, and business acumen abilities.
• Up-to-date knowledge of regulatory guidelines (e.g., GAMP 5, 21 CFR Part 11) and emerging trends in system validation and data integrity.

As an early-career professional in computer system validation, you are responsible for supporting validation tasks within IT systems, focusing on problems of limited scope and complexity. You operate according to defined policies, procedures, and regulatory requirements, using established protocols and quality tools to perform analyses and maintain documentation. Your decision-making occurs within a structured framework, drawing on standardized practices to address validation activities and resolve deviations. You are actively developing your understanding of GxP regulations, industry standards, and validation processes, and starting to apply these concepts to your work. Most of your contributions are task-specific, such as drafting validation documents, supporting test execution, and collaborating with your immediate project team. You work under moderate supervision, receiving clear, detailed guidance, and your main interactions are with team members and occasionally with cross-functional stakeholders or external vendors during specific validation phases.

Key Responsibilities

• Plan, draft, and maintain validation documentation, including validation plans and specification documentation for Computerized systems
• Develop testing protocols such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Execute validation tests and compile comprehensive phase reports.
• Perform risk analysis and mitigation planning for IT systems, laboratory systems, and manufacturing systems.
• Evaluate and address validation risks associated with system changes, updates, or implementations.
• Collaborate with external system providers during implementation, ensuring alignment with validation requirements and quality standards.
• Act as a subject matter expert during validation-related phases of system upgrades or deployments.
• Maintain detailed and up-to-date validation documentation in compliance with regulatory standards and industry best practices.
• Investigate deviations, discrepancies, or non-conformances encountered during validation activities and ensure corrective actions are appropriately implemented.
• Partner with cross-functional teams to establish validation requirements and ensure project goals align with business and regulatory needs.
• Stay informed of industry developments, evolving regulations, and emerging technologies related to validation processes and systems.

Qualifications

• Min 3 years of experience in a similar role
• Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).
• Proven experience in computer system validation.
• In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).
• Familiarity with AI Validation practices (nice to have).
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.
• Attention to detail and a commitment to quality.

WHAT TAKEDA CAN OFFER YOU:

• Takeda is certified as a Top Employer, not only in India, but also globally. No investment we make pays greater dividends than taking good care of our people.
• At Takeda, you take the lead on building and shaping your own career.
• Joining the ICC in Bengaluru will give you access to high-end technology, continuous training and a diverse and inclusive network of colleagues who will support your career growth.

Benefits:

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

• Competitive Salary + Performance Annual Bonus
• Flexible work environment, including hybrid working
• Comprehensive Healthcare Insurance Plans for self, spouse, and children
• Group Term Life Insurance and Group Accident Insurance programs
• Employee Assistance Program
• Broad Variety of learning platforms 
• Diversity, Equity, and Inclusion Programs
• Reimbursements – Home Internet & Mobile Phone
• Employee Referral Program
• Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 calendar days)

About ICC in Takeda

• Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day.
• As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

#Li-Hybrid

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