Quality Assurance Validation

• 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

Employment Type : Full Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 836192 - 1688247