Sterility Assurance Quality Compliance Sr. Specialist

The Sterility Assurance Quality Compliance Sr.

Specialist provides end-to-end quality oversight for all liquid sterile manufacturing lines (including aseptic filling and terminally sterilized products).

This role owns the site's Contamination Control Strategy (CCS) and serves as the primary authority ensuring total alignment with EU GMP Annex 1 and global regulatory expectations.

Liquid Sterile Lines Oversight Operational Monitoring: oversight routine on-the-floor GxP quality oversight of liquid formulation, sterile filtration, and aseptic filling lines.

Aseptic Interventions: Review and approve Aseptic Process Simulations (APS / Media Fills) designs, parameters, and results.

Sterility Assurance Mapping: Enforce proper cleanroom behaviors, gowning requirements, related utilities compliance, needed testing & monitoring and strict adherence to validated intervention logs.

Microbiological Governance Lab Supervision: Oversee all site microbiological activities, including environmental monitoring (EM), personnel monitoring, utility testing (WFI, Pure Steam, filters, gowns), and product sterility testing.

Data Trending: Actively review and interpret EM and bioburden data to identify adverse microbial trends or emerging risks before excursions occur.

Method Validation: Supervise the development, validation, and execution of rapid microbiological methods and traditional growth promotion testing.

Annex 1 & Contamination Control Strategy (CCS) CCS Ownership: Author, execute, and continuously update the site-wide Contamination Control Strategy (CCS) as mandated by the latest EU GMP Annex 1 revisions & oversee related production, Eng, Micro sections CAPA.

Review & approve related sterile area investigation reports.

Gemba Walk within sterile area related GXP premises / utilities/ systems with needed CAPA follow up.

Gap Analysis: Execute comprehensive gap analyses comparing legacy site processes against current Annex 1 standards.

Risk Assessment: Conduct formal Quality Risk Management (QRM) assessments to identify technical and operational contamination pathways (e.g., personnel, material transfer, HVAC, etc).

CAPA Remediation: Design, track, and implement robust CAPA remediation plans targeting identified alignment gaps and systemic contamination vectors.

Cross-Functional GxP Synthesis Production Interface: Partner with production teams to establish risk-based cleanroom workflows and technical automation controls.

Engineering & Utilities: Collaborate with engineering and production to review automated sterilization cycles (SIP/CIP), dehydrogenation tunnels, autoclave cycles, and HVAC/BMS performance metrics.

Validation Review: oversight validation life-cycle protocols (IQ/OQ/PQ) for new or routine Qualification filling lines, restricted access barrier systems (RABS), and all sanitization systems.

Regulatory Defense: Function as the primary Subject Matter Expert (SME) during health authority inspections regarding all sterility assurance, microbiology, and CCS defenses.