Executive - Process and cleaning validation expert

Role & responsibilities

Hands on experience required on handling of Process validation and Cleaning validation

• Design and execute validation protocols for process and cleaning validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and CV (Cleaning Validation).
• Develop and maintain a validation master plan (VMP) that aligns with regulatory requirements and organizational goals.

• Conduct process validation studies to ensure manufacturing processes consistently produce products that meet predefined quality attributes.
• Analyze process performance and critical parameters during validation runs and document results.
• Ensure adherence to Good Manufacturing Practices (GMP) during all validation activities.

• Develop and execute cleaning validation protocols to confirm the effectiveness of cleaning procedures in removing residues, contaminants, and microorganisms.
• Establish acceptable residue limits and cleaning verification procedures based on product toxicology and batch size.
• Monitor cleaning practices and perform periodic revalidation as required.