Production Manager - API Manufacturing

EVA Pharma

Key Responsibilities:

• Manage end-to-end API production operations, ensuring smooth batch execution, adherence to SOPs, and resolution of operational issues.
• Ensure full compliance with cGMP, EHS, and regulatory standards, including audit readiness and leading deviations, CAPAs, and change controls. and to ensure strict adherence to chemical handling and process safety protocols, drive risk assessments, and promote a zero-incident culture. ensuring proper waste management and environmental compliance.)
• Lead and develop production teams, managing performance, coaching, and fostering a culture of accountability and safety.
• Drive continuous improvement, including Lean/Six Sigma initiatives, yield improvement, cost reduction, OEE enhancement, and downtime reduction.
• Coordinate cross-functionally and manage resources, supporting tech transfers, validation batches, KPI monitoring, and controlling production budgets.

• Bachelor s degree in Pharmacy, Chemical Engineering, Industrial Chemistry, or a related field.
• 10 15 years of experience in pharmaceutical, chemical, or petrochemical manufacturing.
• Minimum 5 years specifically in API production and at least 3 years in a managerial role.
• Strong technical experience in reactors, crystallization, solvent recovery, filtration, drying processes, and participation in regulatory inspections (FDA/EMA preferred).