E-Compliance Specialist Position
3 weeks ago
About the Role
We are seeking an E-Compliance Specialist to join our team at Dr. Reddy's Laboratories Limited. As an E-Compliance Specialist, you will be responsible for executing strategic plans and roadmaps for Computer Systems Validation (CSV) activities, ensuring adherence to timelines, budgets, and quality standards.
Key Responsibilities
- Execute strategic plans and roadmaps for CSV activities, ensuring implementation within timelines, budget, and quality standards.
- Evaluate and collaborate with vendors for CSV activities.
- Perform risk assessments and review action plans to ensure end-to-end compliance.
- Develop and review CSV deliverables for accuracy, consistency, clarity, and completeness.
- Oversee the development of CSV deliverables and coordinate cross-functional team meetings.
- Guide project managers during system implementation and validation processes, ensuring compliance with policies and procedures.
- Ensure compliance with all applicable regulatory requirements, including 21 CFR Part 11.
Qualifications and Skills
- Bachelor's or Master's degree in Computer Science, Information Technology, or a related field.
- 8-15 years of experience in CSV, validation, and compliance.
- Strong understanding of CSV principles, methodologies, and regulatory requirements.
- Ability to perform comprehensive risk and change management for computerized systems.
- Excellent communication, collaboration, and time management skills.
About Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited is a global pharmaceutical company that focuses on providing affordable, high-quality medicines to patients worldwide. Our digital transformation journey is led by the Digital Process and Excellence (DPEx) team, which aims to drive patient-centric innovation and continuous process improvement.
Benefits and Culture
We offer a competitive salary, comprehensive benefits package, and opportunities for career growth and development. Our work culture is built on empathy, dynamism, and a shared purpose to make a positive impact on people's lives.
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