Validation Specialist

Job Description : Validation (Cleaning) / Qualification (Equipment / Instrument)

Key Responsibilities and Functions

This role is responsible for the overall planning, execution, and oversight of Cleaning Validation and Equipment / Instrument Qualification activities, ensuring strict compliance with all internal policies and external regulatory guidelines (cGMP, FDA, EMA, WHO, etc.).

Planning & Strategy

• Develop and maintain comprehensive validation plans :
• Develop and update the Cleaning Validation Master Plan covering both Oral Solid Dosage (OSD) and Small Volume Parenteral (SVP) product lines.
• Maintain equipment qualification master plans and documentation within a validated document management system.
• Conduct Risk Assessments and Define Criteria :
• Participate in risk assessments (worst-case, cleaning agent, product carryover) to define cleaning limits.
• Determine acceptance criteria for residues ( API, excipient, cleaning agent ).
• Identify worst-case equipment, product, and process parameters for cleaning validation.

Protocol / Documentation

Execution & Oversight

Cross-Functional Collaboration

Training & Competency

Continuous Improvement

Skills Required

Cleaning Validation, equipment qualification