Validation Specialist - Risk & Compliance
- Bangalore, Karnataka
- Permanent
- Full-time
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
- 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.
- 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.
- 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)
- 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.