
Operations Analyst
3 days ago
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
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