eCompliance Specialist

We are seeking a highly skilled eCompliance Specialist to join our Digital Process and Excellence (DPEx) team at Dr. Reddy's Laboratories Limited. As a key member of our team, you will play a crucial role in executing strategic plans and roadmaps for Computer Systems Validation (CSV) activities, ensuring adherence to timelines, budgets, and quality standards.

• 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.
• Define risk-based strategies for system validation, including validation methodologies, testing activities, documentation, and version release protocols.
• Develop and review CSV deliverables for accuracy, consistency, clarity, and completeness.
• Assist project managers during system implementation and validation process, ensuring compliance with policies and procedures.
• Train users and appropriate personnel on CSV, quality, and compliance.
• Ensure compliance to all applicable regulatory requirements.
• Review change controls related to business processes and IT system changes.
• Establish and implement corrective and preventive actions, as well as lead process improvement initiatives for CSV projects.
• Face regulatory, customer, and IT Quality System-related inspections for all computerized systems across the organization.
• Undertake knowledge management initiatives such as GxP awareness, compliance sustenance, and Trainer-Training sessions related to CSV, quality, and compliance for cross-functional teams.
• Develop and modify procedures for CSV activities and related system-specific qualification activities.

• Bachelor's or Master's in Computer Science, Information Technology, or related field.
• Minimum 8 to 15 years of experience in CSV validation and compliance.
• Strong understanding of CSV principles and methodologies, including risk-based validation strategies, testing protocols, and documentation requirements.
• Proficiency in regulatory requirements related to CSV, such as 21 CFR Part 11, Annexure 11, and GAMP guidelines.
• Experience with validation tools and software, including validation lifecycle management systems (VLMS) and electronic document management systems (EDMS).
• Familiarity with IT Change Management processes and change control procedures in regulated environments.
• Strong understanding of quality management systems (QMS), quality assurance (QA), and compliance frameworks.
• Ability to perform comprehensive risk and change management for computerized systems.
• Foundational knowledge on manufacturing and automation in the context of computerized systems validation.

At Dr. Reddy's Laboratories Limited, we offer a competitive salary and benefits package, as well as opportunities for career growth and professional development. Our work culture is built on empathy and dynamism, and we foster a collaborative environment that encourages teamwork and shared success.

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.