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