Job Title : Operations Analyst (OA)- VDSP, Lalru & VDPP, Baddi
Location : Baddi, Himachal Pradesh & Lalru, Punjab
Role Summary :
To enable data-driven decision-making and support operational excellence across Drug Substance and Drug Product manufacturing by developing performance dashboards, conducting variance analyses, and ensuring strict adherence to WHO-GMP standards in a vaccine production environment.
Key Responsibilities :
- Real-Time Operations Dashboarding : Develop and maintain real-time dashboards covering both DS and DP stages, including Overall Equipment Effectiveness (OEE) , batch yield, deviation trends, downtime analysis, and key quality metrics.Automate daily / weekly / monthly dashboard for COO and senior management.
- Cross-Functional Variance Analysis : Conduct detailed analysis on capacity vs. utilization, cycle time efficiency, cost variances, and manpower / productivity tracking for both DS and DP areas.
- Compliance & Quality Support : Ensure reporting systems align with WHO-GMP, data integrity, and audit-readiness requirements. Track deviations, CAPAs, and maintain metrics related to compliance performance.
- Support Process & Business Reviews : Provide insights and reports for Monthly Operating Reviews (MOR), Quarterly Business Reviews (QBR), and regulatory submissions related to manufacturing performance.
- Operational Performance Insights : Identify trends, bottlenecks, and improvement opportunities across upstream (fermentation / cell culture, purification) and downstream (formulation, filling, packaging) processes in Vaccine Drug Substance Plant and finished production in different production lines in Vaccine Drug Product Plant.
- Integration with QA / QC and Production Teams : Work closely with QA / QC, Production, Engineering, and Supply Chain to collect, validate, and analyze operational data for continuous improvement initiatives.
- Support for Technology Transfers and Scale-Up : Assist in data analysis and visualization during product scale-up, tech transfer, and new product introduction activities.
- Data Analysis and reporting :
Use data tools (Excel, Power BI, Netsuite , ERP, eQMS etc. ) to extract , analyze and visualize operational data .
Assist in preparation of performance review decks, executive summaries and plant update .Qualifications & Experience :
Bachelor’s / Master’s degree in Engineering, Pharmacy, Biotechnology, data science or related field.4–5 years of demonstrated experience in pharmaceutical / vaccine operations analytics,Familiarity with both Drug Substance (upstream / downstream) and Drug Product (formulation / fill-finish) processes.Experience with Excel, Power BI / Tableau, and ERP / MES / LIMS systems is essential.Key Skills & Competencies :
Strong analytical and problem-solving skillsThorough understanding of GMP, data integrity, and WHO regulatory expectationExcellent communication and coordination skillsFamiliarity with batch documentation, deviation trending, and production KPIsProactive approach to identifying process improvement opportunities