Descripción de la oferta
AP QA Specialist (Aseptic Processing) - FDA Readiness
Contract: 2 months, 40 hours/week
Start: Immediate (FDA readiness deadline: June)
Level: Mid‑Senior Specialist
About the Role
A leading pharmaceutical manufacturer is seeking an experienced AP QA Specialist to support critical aseptic processing readiness activities ahead of an upcoming FDA milestone. This role requires a hands‑on specialist capable of delivering rapid, compliant results within a fast‑paced remediation environment.
Key Responsibilities
Aseptic Process Compliance & Review
Conduct a retrospective review of 2024-2025 media fills on BS3 and IWK3, mapping operators to interventions and confirming compliance.
Review all authorized aseptic interventions and verify appropriateness of related mitigation measures.
Perform a complete Aseptic Process Simulation (APS) rational review.
Risk Assessment & QA Oversight
Update risk assessments for direct and indirect product‑contact surfaces in aseptic processes.
Conduct an impact assessment supporting the justification of current Preventive Maintenance (PM) acceptance criteria.
Perform a risk‑based evaluation of validated interventions, defining worst‑case scenarios.
Review and classify maintenance activities to establish appropriate QA oversight requirements.
Set‑Up, Personnel Monitoring & Readiness
Review IWK3 and BS3 set‑up processes, defining the validated sequence and the point at which equipment achieves Grade A readiness for EM sampling.
Update assessment of personnel monitoring limits across aseptic operations.
Evaluate glove‑sampling practices, including the assessment of using one plate per glove.
Quality Alarm Management
Review management of quality alarms in SCADA, ensuring proper acknowledgement, justification, root cause analysis, and QA oversight.
Requirements
5+ years in aseptic processing, sterile manufacturing, or pharmaceutical QA.
In‑depth understanding of EU Annex 1 and FDA aseptic guidance.
Proven experience with media fills, interventions, equipment readiness, and risk‑based decision making.
Ability to join mid‑stream and deliver results quickly.
Strong communication, analytical, and documentation skills.
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