Quality Assurance Validation
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Job Summary
Protocol Design: Write and execute validation protocols ($IQ/OQ/PQ$) to prove cleaning procedures consistently remove product residues detergents and microbes.
Risk Assessment: Identify worst-case scenarios such as the hardest-to-clean equipment or the most toxic chemical residues to focus validation efforts where they matter most.
Sampling Management: Determine acceptance criteria and oversee sampling methods including swab and rinse sampling to verify surface cleanliness.
Analytical Testing Alignment: Partner with Quality Control ($QC$) laboratories to ensure analytical test methods (like HPLC or TOC analysis) are sensitive enough to detect trace residues.
Data Analysis: Evaluate statistical data author comprehensive validation summary reports and present findings during regulatory audits (e.g. FDA or EMA).
Cycle Development: Collaborate with engineering and operations teams to optimize Automated Clean-in-Place ($CIP$) and manual Clean-out-of-Place ($COP$) cycles.
Deviation Investigation: Lead root-cause investigations when cleaning limits are breached implementing Corrective and Preventive Actions ($CAPA$).
Change Control Execution: Assess how modifications to manufacturing equipment chemical formulations or batch sizes impact the validated cleaning status.
Revalidation Program: Manage periodic monitoring schedules to guarantee that equipment remains in a continuous state of validated control over time.
Regulatory Compliance: Maintain strict adherence to Current Good Manufacturing Practices ($cGMP$) ensuring the facility meets changing global health authority standards.
Required Experience:
Manager
