Purpose

To execute and support cleaning validation activities for manufacturing equipment, process equipment, utensils, and associated systems in compliance with current Positive Manufacturing Practices (cGMP), regulatory requirements, and company procedures. The role is responsible for preparation and execution of cleaning validation protocols, sampling activities, documentation, investigation of validation deviations, and maintenance of the cleaning validation lifecycle.

Position / Job Title Executive

Department Quality Assurance – Cleaning validation

Reporting To Senior Manager- Quality Assurance

Location Pithampur

Years of Experience 5-8 Years

Dosage Form Solid Oral

Job Responsibilities / Deliverables

Cleaning Validation

Prepare, review, and execute Cleaning Validation Protocols and Reports for manufacturing equipment, utensils, and ancillary equipment.

Perform risk assessment for equipment grouping, product matrixing, and worst-case product selection.

Support development and maintenance of the Cleaning Validation Master Plan.





Ensure cleaning validation activities comply with approved protocols and procedures.

Sampling Activities

Perform or coordinate swab and rinse sampling following validated sampling procedures.

Ensure correct identification, handling, storage, and transfer of validation samples to the Quality Control laboratory.

Verify sampling locations based on equipment design and worst-case considerations.

Validation Execution

Coordinate execution of cleaning validation studies with Production, Quality Control, and Engineering departments.

Verify equipment cleanliness before validation execution.

Ensure required documentation is completed accurately during validation activities.

Acceptance Criteria

Verify Cleaning Validation Acceptance Criteria Based On

Health-based exposure limits (HBEL/PDE), where applicable.

Maximum Allowable Carryover (MACO).

Visual cleanliness.

Analytical acceptance criteria.

Microbiological acceptance criter

📌 Executive (Indore)
🏢 Rubicon Research
📍 Indore