CSV Senior Analyst

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 Computer System Validation (CSV) Senior 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.

• Key Responsibilities

• Oversee the development and review of comprehensive validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices.

• Conduct risk assessments for computer systems, identify potential vulnerabilities, and implement risk mitigation strategies.

• Establish and maintain a robust change control process to manage system changes and updates in compliance with validation requirements.

• Provide guidance on validation testing methodologies, including test design, execution, and documentation. Ensure that testing meets regulatory expectations.

• Work with other departments to ensure alignment for an agreed upon state of control for computer systems.

• Practice and stay current with ISPE GAMP best practices, FDA and EU GxP regulations, and applicable ISO standards.

• Manage a team of professionals to drive validation activities for computer systems.

• Work with other departments to ensure alignment for an agreed upon state of control for computer systems.

• Provide training and guidance to team members on validation processes and procedures.

Qualifications

• Min 5 years of experience in a similar role

• Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).

• Proven experience in 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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