QA (Cleaning Validation)

Position: Executive / Assistant Manager QA (Cleaning Validation)
Department: Quality Assurance
Industry: Pharmaceutical – Injectable
Experience: 6–10 years in QA / Cleaning Validation

Job Purpose

Responsible for planning, execution, review, and compliance of cleaning validation activities for injectable manufacturing facilities in accordance with GMP and regulatory requirements.

Key Responsibilities

• Prepare and review Cleaning Validation protocols, reports, SOPs, and risk assessments.
• Coordinate and monitor cleaning validation activities for manufacturing equipment, product-contact parts, and production areas.
• Review sampling plans, swab/rinse sampling, analytical results, and acceptance criteria.
• Ensure compliance with GMP, SOPs, validation procedures, and regulatory requirements.
• Manage cleaning validation deviations, investigations, CAPA, and change controls.
• Coordinate with Production, QC, Engineering, and Validation teams for execution of validation activities.
• Support regulatory/customer audits and ensure timely closure of observations.
• Maintain cleaning validation documentation and periodic review/revalidation requirements.
• Identify opportunities for improving cleaning processes and validation practices.

Qualification

B.Pharm / M.Pharm / B.Sc / M.Sc or relevant qualification.

Key Skills

Cleaning Validation • QA • GMP • Risk Assessment • Protocol/Report Preparation • Swab & Rinse Sampling • Deviation/CAPA • Change Control • Audit Compliance • Injectable Manufacturing