Validation Specialist

Key Responsibilities and Functions

This role is responsible for the overall planning, execution, and oversight of Cleaning Validation

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

• Validation and Qualification Documentation:

• Prepare, review, and approve cleaning validation protocols, verification, monitoring, and revalidation documents.

• Prepare and maintain

  Standard Operating Procedures (SOPs)

  related to cleaning procedures and validation.
• Maintain and review cleaning validation reports, summaries, and conclusion documents.
• Develop and review

  qualification protocols and reports

  (IQ, OQ, PQ) to ensure compliance.

• Compliance:

• Ensure alignment with regulatory guidelines (cGMP, FDA, EMA, WHO, etc.).

• Ensure all qualification activities follow

  Good Documentation Practices (GDP)

  and comply with

  Good Manufacturing Practices (GMP)

  .

Execution & Oversight

• Cleaning Validation Execution:

• Conduct, or oversee, the execution of cleaning validation studies in OSD and SVP areas

  , including three consecutive validation runs or as per requirement.
• Supervise

  swab/rinse sampling

  , worst-case cleaning cycles, and cleaning agent effectiveness.
• Monitor periodic verification, cleaning monitoring, and revalidation as per schedule.

• Equipment Qualification Execution:

• Plan and execute equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

  .
• Support

  requalification

  and

  periodic review

  programs as per change control or deviation management systems.
• Ensure equipment qualification interfaces (utilities,

  Clean-in-Place/Sterilize-in-Place (CIP/SIP)

  etc.) are met.

Cross-Functional Collaboration

• Internal Coordination:

• Work with Production, Quality Control (QC), Engineering, and R&D (if applicable) for New Product Introduction (NPI)

  or product transfers for cleaning validation requirements.
• Coordinate with analytical labs for method validation and sample analysis.
• Coordinate with engineering, quality, manufacturing, and vendors to gather technical documentation, calibration records, and user requirements for qualification.

• Quality System Support:

• Participate in Corrective Action/Preventive Action (CAPA)

  ,

  change control

  , and

  deviation investigations

  related to cleaning validation.
• Support

  audits and regulatory inspections

  related to cleaning validation.

Training & Competency

• Training Delivery:

• Train and support manufacturing, QC, Quality Assurance (QA), and engineering personnel on cleaning procedures, sampling methods, and documentation.

• Ensure the team is aware of current regulatory expectations and internal policies regarding cleaning and qualification.

Continuous Improvement

• Process Optimization:

• Review existing cleaning processes and procedures for optimisations

  (efficiency, cost, sustainability, reduction of cleaning time or water/solvents usage).
• Implement improvements based on data trending, risk assessment, and root cause analysis.

• Program Management:

• Maintain a program of periodic review/revalidation

  as needed.