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Key skills for this role
• Operation and maintenance of Purified Water Generation & Distribution System, WFI Generation & Distribution Systems, Pure Steam Generation & Distribution Systems of A, B & C Buildings as per their respective EOPs.
• Scheduled activities i.e. Preventive Maintenance, Weighing Balance Performance Verification, Performance Verification of Pure Steams, Vent Filters integrity testing’s, Descaling of MCDPs, Hydro test of the distribution systems & DE-roughing activity of the distribution systems.
• Maintain spares inventory and material planning to ensure optimal stock levels while minimizing inventory costs.
• Execute Quality Management System (Veeva) activities including Change Control, Deviations, and CAPA in accordance with procedures.
• Prepare qualification documents (IQ/OQ/PQ) and execute qualification activities for Clean Utility equipment.
• Investigate discrepancies, deviations, and failures; perform root cause analysis and implement CAPA effectively.
• Ensure timely issuance, review, and submission of clean utility equipment records and logbooks through the Documentation Cell.
• Ensure full compliance with GMP, SOPs, and regulatory requirements during all operational and maintenance activities.
Pune Biotech, MH, IN
Operation and maintenance of Purified Water Generation & Distribution System, WFI Generation & Distribution Systems, Pure Steam Generation & Distribution Systems of A, B & C Buildings as per their respective EOPs.
Scheduled activities i.e. Preventive Maintenance, Weighing Balance Performance Verification, Performance Verification of Pure Steams, Vent Filters integrity testing’s, Descaling of MCDPs, Hydro test of the distribution systems & DE-roughing activity of the distribution systems.
Maintain spares inventory and material planning to ensure optimal stock levels while minimizing inventory costs.
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Execute Quality Management System (Veeva) activities including Change Control, Deviations, and CAPA in accordance with procedures.
Prepare qualification documents (IQ/OQ/PQ) and execute qualification activities for Clean Utility equipment.
Investigate discrepancies, deviations, and failures; perform root cause analysis and implement CAPA effectively.
Ensure timely issuance, review, and submission of clean utility equipment records and logbooks through the Documentation Cell.
Ensure full compliance with GMP, SOPs, and regulatory requirements during all operational and maintenance activities.
2 - 3 Years Experience for Water System Operation & Maintenance
Public Indian pharmaceutical company developing and manufacturing generics, specialty medicines, biosimilars, and APIs for patients worldwide.
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Entry · 2+ years experience
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