executive

Purpose

To execute and support cleaning validation activities for manufacturing equipment, process equipment, utensils, and associated systems in compliance with current Good 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 criteria, where applicable.

Documentation

Prepare and maintain validation protocols, reports, summary reports, and associated documentation.

Ensure documentation complies with Good Documentation Practices (GDP) and ALCOA+ Data Integrity principles.

Maintain cleaning validation schedules and validation status records.

Investigation and CAPA

Participate in investigations related to cleaning validation failures, deviations, out-of-limit results, and revalidation activities.

Assist in root cause analysis and implementation of Corrective and Preventive Actions (CAPA).

Support change control assessments related to cleaning processes and equipment.

Periodic Review and Revalidation

Support periodic review of validated cleaning procedures.

Recommend revalidation following equipment modification, product change, cleaning process changes, or regulatory requirements.

Cross-Functional Coordination

Coordinate with Production, Quality Control, Engineering, Maintenance, and Quality Assurance for planning and execution of validation activities.

Ensure timely completion of validation activities to support manufacturing schedules.

Audit Support

Support internal audits, customer audits, and regulatory inspections by providing cleaning validation documentation and technical explanations.

Assist in responding to audit observations related to cleaning validation.

Additional Job Responsibility

change request evaluation with respect to change in API, manufacturing process, equipment cleaning procedure, change in equipment train

Risk assessment with respect to change in cleaning process, new equipment introduction,

GAP assessment with respect to current regulatory requirement

Ensure all QMS are closed as per SOP timeline.

Review of calibration activity as per defined schedule frequency.

Review of preventive maintenance activity as per defined frequency.

Review of requalification activity as per defined frequency.

Preparation and review of QA department SOPs.

Good knowledge about current trends of Data integrity.

Good knowledge about current Regulatory Guidance and requirement

Qualifications & Pre-requisites

Must-Have Skills: B Pharmacy/ M. Pharmacy

Must have knowledge on handling Qualification and validation.

Exposure to various regulatory bodies like US FDA, MHRA, TGA.

Exposure to specific dosage forms like OSD.

Team coordination and work distribution.

Good communication skill which results to coordination with functions like QC, Manufacturing, Engineering, Warehouse Regulatory.