Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this current and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape
The Analyst, Safety Label Change (SLC), is responsible for supporting the implementation, monitoring, and governance of safety-related labeling changes across global markets. The role is responsible for tracking key milestones, monitoring KPIs, ensuring compliance with GMP/GxP and regulatory requirements, coordinating with cross-functional stakeholders, and supporting timely execution of safety-related labeling changes across the global Sandoz network.
Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Ensure compliance with Sandoz quality standards, GxP requirements, and applicable regulatory requirements.
Support continuous improvement initiatives to enhance process quality, efficiency,
and compliance.
Escalate deviations, risks, and compliance issues in a timely manner and support CAPA implementation.
Support audits, inspections, and quality-related activities.
Ensure adherence to approved SOPs, Working Procedures, and governance requirements.
Role-Specific Accountabilities – Safety Label Change
Monitor and track Safety Label Change (SLC) implementation milestones and KPIs.
Identify process gaps, delays, and compliance risks and proactively drive resolution.
Coordinate with Packaging Sites, Regulatory Affairs, Quality Assurance, Patient Safety, Pharmacovigilance, Supply Chain, and other stakeholders to ensure successful implementation of safety-related changes.
Maintain and analyze large datasets related to SLC implementation and compliance metrics.
Develop, maintain, and automate dashboards and reports using advanced Microsoft Excel tools to support KPI monitoring, data an
📌 Analyst- Safety Label Change (India)
🏢 Sandoz
📍 India