09 Aug
|
Sandoz India
|
Telangana
09 Aug
Sandoz India
Telangana
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 analysis, trend identification, and reconciliation activities.
- Conduct monthly reviews of milestone deviations and support CAPA implementation.
- Prepare management reports, presentations, and performance metrics for leadership reviews.
- Support audits and inspections related to Safety Label Changes.
- Contribute to continuous process improvement initiatives and operational excellence projects.
- Maintain accurate documentation, trackers, and service performance dashboards.
Essential Requirements What you’ll bring to the role:
- Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
- 2–5 years of experience in Safety Label Change, Pharmaceutical Operations, Artwork Operations, Regulatory Affairs, Pharmacovigilance, Quality Operations, Labeling Operations, or Supply Chain functions.
- Experience working with global stakeholders and cross-functional teams preferred.
- Working knowledge of GMP/GxP and quality systems preferred.
Professional Competencies
- Strong analytical, reporting, and communication skills (written and verbal).
- Knowledge of GMP/GxP, Quality, Regulatory, and Pharmacovigilance processes.
- Effective stakeholder management and cross-functional collaboration.
- Project coordination and problem-solving capabilities.
- Continuous improvement and operational excellence mindset.
- Advanced proficiency in Microsoft Excel, including Pivot Tables, XLOOKUP/VLOOKUP, data validation, dashboard creation, reporting, and data analysis. Knowledge of Power Query and VBA/macros is an added advantage.
Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, production sites, recent acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Join us!
📌 Analyst- Safety Label Change (Telangana)
🏢 Sandoz India
📍 Telangana