GXP Gatekeeper for In center

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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: 

As a GXP Gatekeeper in the In-Center Capability within the Plasma-Derived Therapies (PDT) business unit, you will independently oversee all aspects of quality standards, ensuring every documentation quality meets the expectations of the Takeda ISQA, and Takeda Quality Standards. Your contributions will be crucial in reducing defects and review cycles. Collaborating closely with multiple stakeholders across In-Center projects, you will coordinate and manage risks to meet documentation deliverable timelines.

By defining and maintaining quality standards, this role ensures Takeda’s processes meet QA expectations and industry best practices, enhancing decision-making and competitive advantage. You will drive continuous improvement, manage risks, maintain quality records, and provide training and support to team members. Coordinating deliverables and integrating feedback, you will help Takeda innovate, adapt, and evolve in a dynamic business and technological landscape.

This position will align to Testing and Validation chapter of the ICC and initially report to the Functional Delivery Lead for strategic direction as well as day-to-day management until the role of QA Lead is filled within Takeda ICC, post which the reporting and managerial responsibilities will be transitioned accordingly.

How you will contribute:

• Execute Computer System Validation (CSV) activities for GxP applications, laboratory systems, manufacturing systems, and enterprise platforms.
• Contribute and ensure adherence of different software applications to the designated change control processes
• Develop and review validation documentation including: Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications, Design Specifications, Test Scripts (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Ensure compliance with regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q7/Q10) and company SOPs.
• Collaborate with cross-functional teams (QA, IT, Manufacturing, R&D, and Business Units) to ensure timely validation delivery.
• Perform risk-based assessments to prioritize validation testing.
• Provide audit support for regulatory inspections and internal quality audits.
• Train project teams on CSV processes, documentation standards, and compliance requirements.
• Participate in data integrity assessments and remediation projects.
• Support continuous improvement of CSV procedures, templates, and best practices.

Minimum Requirements/Qualifications:

• Bachelor’s or Master’s degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field.
• 3–5+ years of experience in Computer System Validation within GxP-regulated industries (pharma, biotech, medical devices).
• Strong knowledge of GAMP 5 guidelines, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
• Experience validating Laboratory systems (e.g., LIMS, CDS, ELN), Manufacturing systems (e.g., MES, SCADA, PLCs), ERP (SAP), or Cloud-based systems.
• Hands-on experience with risk-based validation approaches.
• Excellent documentation, analytical, and communication skills.
• Ability to work independently and manage multiple projects simultaneously.

Preferred requirements:

• Experience with cloud/SaaS validation (AWS, Azure, Veeva, etc.).
• Experience with Testing Tools like Jeera, qTest and ALM
• Knowledge of Agile / SDLC methodologies and their application in CSV.
• Prior involvement in regulatory inspections and client audits.
• Familiarity with 21 CFR Part 820 (Medical Devices) and ISO standards (ISO 13485, ISO 14971).

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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