CSV - Senior Analyst

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 Validation Lead 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:

Develop, initiate, and oversee risk-based validation strategies and procedures to ensure compliance with regulatory standards and industry best practices for IT systems and processes. Lead validation planning, execution, and reporting across the organization, including risk assessments, validation deliverables, documentation updates, and driving remediation of issues. Establish, monitor, and report Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs) for validation effectiveness and compliance. Collaborate with business and technology leaders to communicate validation risks and ensure a clear understanding of their impact and required actions. Provide leadership in advancing validation frameworks and documentation processes, aligning with business goals and compliance requirements. Guide and mentor validation team members to develop their expertise and ensure the successful delivery of projects in adherence to Takeda’s compliance standards. Continuously improve validation processes by adopting innovative tools and methodologies to enhance efficiency and effectiveness while maintaining regulatory compliance. Coordinate with cross-functional teams to ensure a seamless approach to validation and compliance initiatives enterprise-wide.

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 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.

#Li-Hybrid

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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