Location: [Not specified in the provided description]
The SCO – Validation Lead is a critical leadership position responsible for managing and executing the global computer system validation (CSV) program. This role ensures compliance with regulatory standards, mitigates information security risks, and supports business objectives by implementing robust validation processes.
Strategic Validation Planning:
Develop and execute a CSV strategy that aligns with the company's compliance and quality goals, incorporating risk assessment methodologies and lifecycle models.
Validation Documentation:
Oversee the creation and review of validation plans, protocols (IQ/OQ/PQ), traceability matrices, and validation reports to ensure comprehensive compliance.
Risk Assessment:
Conduct detailed risk assessments of computer systems, identify vulnerabilities, and implement effective risk mitigation strategies.
Change Control Process:
Establish and maintain a change control process to manage system updates while adhering to validation requirements.
Testing Methodologies:
Guide testing methodologies, from design to execution, ensuring alignment with regulatory standards and validation expectations.
Regulatory and Industry Alignment:
Stay updated on regulatory requirements and best practices (GAMP 5, 21 CFR Part 11, ISO standards, FDA, and EU GxP regulations) to inform and enhance validation activities.
Collaboration and Cross-Departmental Alignment:
Partner with internal teams to maintain a cohesive and compliant state of control for computer systems.
Team Management:
Lead and mentor a team of validation professionals to meet program goals effectively.
Experience:
Educational Background:
Technical Knowledge:
Skills:
The role demands technical expertise, leadership skills, and a collaborative mindset to align cross-functional teams. A commitment to continuous learning, adherence to global regulatory standards, and strategic thinking will ensure success in this role.
This role offers a dynamic opportunity to shape Takeda's global CSV strategy while contributing to its mission of delivering innovative, high-quality therapies to patients worldwide.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Ranchi |Karnataka :
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Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
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Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
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