Risk & Compliance Specialist

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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 epicentre 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.

Key Responsibilities

• Develop and execute a strategic CSV plan that aligns with the company's overall compliance and quality objectives. This includes defining validation strategies, risk assessment methodologies, and validation lifecycle models.
• 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.

Qualifications

• Min 8 years of experience in a similar role
• Bachelors or Master's degree in a relevant scientific or engineering discipline (e.g., Computer Science, Engineering, Chemistry, Pharmacy, or related fields).
• Extensive experience in computer system validation, particularly in laboratory, R&D and clinical trial environments.
• 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).
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
• Attention to detail and a commitment to data integrity and quality.

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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