QC Validation Specialist (IQ/OQ/PQ)

We are seeking a hands-on QC Validation Specialist to support equipment and instrument qualification within a pharmaceutical cGMP environment. The ideal candidate will have strong experience in IQ, OQ, and PQ protocols, validation documentation, and QC operations.

Responsibilities:

• Perform equipment and instrument qualification activities.

• Author, execute, and review IQ, OQ, and PQ protocols.

• Prepare validation reports, SOPs, and controlled documentation.

• Support deviations, discrepancies, and qualification closeout.

• Coordinate with QC, QA, and Manufacturing teams.

• Ensure compliance with cGMP, GDP, and applicable 21 CFR requirements.

Requirements:

• Minimum 3 years of experience in pharmaceutical, biotech, or regulated manufacturing.

• Strong hands-on experience with IQ, OQ, and PQ.

• Experience in QC Validation, equipment qualification, or instrument qualification.

• Knowledge of cGMP, GDP, and validation documentation.

• Strong technical writing and documentation skills.

Preferred:

• IOQ experience.

• Environmental monitoring, Climet instruments, particle counters, or cleanroom experience.

• QC Chemist background with strong validation experience.