Sr. Associate
3 days ago
Job Description Summary
- Operation & Maintenance: Oversee the purified water and water for injection (WFI) systems, ensuring compliance with pharmacopoeiastandards.
- System Qualification: Implement Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for water
systems
- Compliance & Documentation: Maintain Standard Operating Procedures (SOPs) and ensure adherence to regulatory guidelines.
- Troubleshooting & Optimization: Identify and resolve system inefficiencies, ensuring continuous improvement.
Job Description
• Knowledge of water purification technologies (Pretreatment, Reverse Osmosis, Deionization (EDI), Distillation (WFI)).
• Understanding of GMP & regulatory requirements (WHO, FDA, EU GMP).
• Technical expertise in system validation & maintenance.
• Problem-solving & analytical skills.
- Safety & Environmental Regulations: Ensure compliance with health, safety, and environmental standards.
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