Executive - QC Instrumentation

Role Purpose

The incumbent will be responsible for maintenance, calibration, qualification, and troubleshooting of QC laboratory instruments in a USFDA‑regulated environment, ensuring continuous compliance and minimal downtime.

Key Responsibilities

• Perform preventive, breakdown, and corrective maintenance of QC analytical instruments.
• Handle installation, qualification (IQ/OQ/PQ), calibration, and validation support for QC instruments.
• Troubleshoot hardware/software issues related to analytical instruments.
• Ensure compliance with USFDA, cGMP, ALCOA+, and data integrity requirements.
• Maintain instrument lifecycle documentation, logbooks, calibration records, and SOPs.
• Coordinate with external service engineers and instrument vendors.
• Support internal, regulatory, and customer audits (USFDA, MHRA, WHO, etc.).
• Ensure proper change control, deviation handling, and CAPA related to instruments.
• Participate in periodic review, risk assessment, and continuous improvement activities.
  
  

• HPLC / UHPLC
• GC / Headspace GC
• UV–Visible Spectrophotometer
• IR / FTIR
• Dissolution Apparatus
• Karl Fischer Titrator
• TOC Analyzer
• pH Meter, Conductivity Meter
• Stability Chambers and other analytical instruments
  
  

• Diploma / BE / BTech in any of the following disciplines:
• Electrical
• Mechanical
• Instrumentation
• Electronics
• Mechatronics

• 4 to 9 years of hands‑on experience in QC instrument maintenance within:
• USFDA‑approved pharma manufacturing units OR
• Regulated QC laboratories

• Strong understanding of QC instrumentation and compliance requirements
• Hands‑on troubleshooting capability
• Knowledge of 21 CFR Part 11 and data integrity
• Ability to work in regulated and audit‑driven environments
• Good documentation and coordination skills