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 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.
