AL

Executive - Process and cleaning validation expert

Alembic Pharmaceuticals
Vadodara5-8 LPA Posted 9 May 2025
FULL TIME
Cleaning Validation
Process Validation

Job Description

  • 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.
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