Validation Specialist  - Risk & Compliance

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 Digital Risk and Compliance, Sr. Analyst is responsible for managing the global information security risk program across the organization. This individual collaborates with business leaders to understand security and risk issues, oversees risk management and assessment efforts, and develops effective remediation programs. This role supports Takeda's mission by ensuring the security and compliance of IT systems and processes.

How you will contribute:
* Develop, initiate, and maintain global policies and procedures for the operation of the compliance program to prevent illegal, unethical, or improper conduct with IT systems and processes
* Lead and govern the measurement and reporting of risks across the organization, including documentation updates, scoping, assessments, management reporting, and driving remediation of issues
* Establish, monitor, and report KPIs and Key Risk Indicators
* Communicate and present key security risks at various levels, including business and technology leaders, to ensure a clear understanding of these risks
* Provide leadership in maturing the global information security risk management program, including enterprise security reporting and metrics processes to meet the ongoing needs of the business
* Organize and host internal and third-party audits, providing audit oversight and managing post-audit corrective actions
* Coordinate with other groups responsible for risk management areas

Skills and qualifications:

• Must have experience working in agile environment and use of modern quality tools ( e.g. ( JIRA, Confluence, Qtest, etc)
• Working knowledge of manufacturing IT systems like LIMS,MES, TrackWise,etc.
• Experience working with virtual teams on a global basis
• In depth knowledge of GxP regulations( such as from FDA, EMA, etc) related to Manufacturing  IT systems
• Ability to lead teams in the correct interpretation of regulations
• Good oral and written communications skills, business acumen with problem solving and analytical skills

As an early-career professional, you handle problems of limited scope and complexity, adhering to established policies and procedures. Your decision-making is within a defined scope, using standardized methods to analyze situations and data. You are developing knowledge of basic principles, theories, and concepts, and beginning to apply industry practices and standards. Typically, this role requires some relevant experience, with contributions mostly related to task-specific activities. Your primary contacts are with your immediate team, and you work under moderate direction and close supervision, following specific, detailed instructions.

• Key Responsibilities
• 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.
• Provide expertise and guidance on validation processes to project teams and stakeholders.
• Provide training and mentorship to team members and stakeholders regarding validation processes, protocols, and best practices.
• Serve as a go-to expert for validation-related challenges and initiatives.
• Stay informed of industry developments, evolving regulations, and emerging technologies related to validation processes and systems.
• Continuously integrate improvements and ensure alignment with regulatory guidelines.

Qualifications

• 8-10  years of experience in a similar role
• Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).
• Proven experience infrastructure qualification and 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 cloud qualification 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.

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