Abrar Admin

i-Pharm GxP

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 Overview:
 
 
 
 We are supporting a pharmaceutical organization undertaking a Six Sigma-driven transformation within its PQC function. The initiative is focused on improving operational efficiency, reducing process redundancy, and strengthening the linkage between issue identification and execution of corrective actions.
 
 
 The project is currently in the assessment phase, following a recent site-wide diagnostic that highlighted inefficiencies in workflows, prioritization challenges, and reliance on manual processes. This consultant will play a key role in evaluating current state operations and driving pragmatic, high-impact improvements across the lab environment.
 
 
 
 
 
 
 Key Responsibilities:
 
 
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 Lead assessment of PQC workflows, identifying inefficiencies, redundancies, and process gaps
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 Drive implementation of Six Sigma principles to optimize lab operations and throughput
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 Improve prioritization frameworks and workflow clarity across QC activities
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 Bridge gaps between deviation identification and timely, effective remediation
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 Partner with lab leadership and cross-functional teams to implement sustainable improvements
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 Support or rebuild elements of the Quality Management System (QMS) where required
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 Provide hands-on support within lab operations, including analytical processes where needed
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 Deliver pragmatic, risk-based solutions focused on high-impact, achievable improvements
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 Environment &amp; Tools:
 
 
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 Analytical techniques: HPLC, LCMS (Mass Spectrometry), dissolution testing
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 Systems: Labguru (QMS), MasterControl (QMS), DCOM (inventory management)
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 Team structure: PQC group consisting of Manager, Senior Scientist (method development/validation), and 6 Analysts
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 Required Experience:
 
 
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 Strong background in pharmaceutical Quality and/or Validation environments
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 Proven experience in process assessment, optimization, and remediation initiatives
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 Hands-on experience within GLP-regulated lab environments
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 Experience with lab systems and QMS platforms
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 Demonstrated success reducing manual processes and improving operational efficiency
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 Experience supporting audits (quality, manufacturing) and remediation activities
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 Preferred Experience:
 
 
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 Six Sigma Black Belt (or equivalent practical experience)
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 Prior FDA experience (auditor or industry-facing role)
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 Experience rebuilding or significantly enhancing QMS frameworks
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 Key Traits:
 
 
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 Pragmatic and solution-oriented mindset
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 Ability to prioritize &ldquo;quick wins&rdquo; alongside longer-term improvements
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 Strong stakeholder engagement skills across lab and leadership teams
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 Comfortable working in environments with legacy processes and driving change
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 Additional Requirements:
 
 
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 Willingness to be on-site full-time during initial assessment phase
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 Flexibility to transition to a hybrid model based on project needs
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Quality Assurance Consultant

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i-Pharm GxP

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Quality Assurance Consultant