09 Sep
|
The Pharma Patashala
|
Tupran
09 Sep
The Pharma Patashala
Tupran
Maintenance roles and responsibilities in the pharmaceutical industry ensure that equipment, utilities, and facilities operate safely, efficiently, and in strict compliance with Valuable Manufacturing Practices (GMP). [1, 2]Key Maintenance Roles
Maintenance Technician: Performs routine servicing, lubricating, and hands-on repairs of manufacturing and packaging equipment while troubleshooting mechanical failures. [1, 2]
Calibration Technician: Tests, adjusts, and certifies critical measurement instruments, scales, and sensors to guarantee accuracy and regulatory alignment. [1, 2]
Facilities / Utilities Engineer: Oversees plant infrastructure, including HVAC systems, cleanroom integrity, water systems (Purified Water and Water for Injection), and environmental controls. [1, 2, 3]
Maintenance Planner / Manager: Schedules preventive work orders, manages spare parts inventory, and coordinates internal or contracted personnel. [1]
Core Responsibilities
Preventive and Predictive Maintenance: Executing scheduled inspections, part replacements,
and overhauls to prevent costly equipment breakdowns and product contamination. [1, 2, 3]
Regulatory Compliance & Calibration: Adhering to guidelines like ICH Q7 and 21 CFR Part 211 by verifying that all critical control and testing equipment match certified traceable standards. [1, 2]
Rigorous Documentation: Maintaining accurate equipment logs, standard operating procedures (SOPs), work orders, calibration certificates, and deviation or CAPA reports. [1, 2]
Cleanroom and Utility Upkeep: Monitoring air purity, HEPA filters, room differential pressures, and critical gas/water distribution loops to maintain a sterile manufacturing workplace. [1, 2]
Would you like a detailed breakdown of a Standard Operating Procedure (SOP) for preventive maintenance, or more information on calibration requirements for specific pharma equipment?Role & responsibilities
Preferred candidate profile
📌 Walk In Maintenance Engineer Tupran
🏢 The Pharma Patashala
📍 Tupran