Operations Analyst (OA)- for Vaccine Manufacturing (DS and DP)

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 skills

Thorough understanding of GMP, data integrity, and WHO regulatory expectation

Excellent communication and coordination skills

Familiarity with batch documentation, deviation trending, and production KPIs

Proactive approach to identifying process improvement opportunities