Sterility Assurance Quality Compliance Sr. Specialist

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

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.

Key Responsibilities 

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. 

Qualifications & Experience 

• Deep understanding of RABS technologies and automated filling networks.
• Advanced proficiency in Quality Risk Management tools (FMEA, HACCP) applied to sterile processing.
• Strong track record of successfully managing regulatory inspection questions regarding root cause analysis for sterility failures or EM excursions.
• Teamwork spirit with related function of Production, Eng, Microbiology.
• Bachelor’s degree in microbiology, pharmaceutical sciences, or a related life sciences discipline. 
• 4-7 years of experience in sterile pharmaceutical manufacturing QA.
• Minimum of 5 years supervising microbiological laboratories or leading cross-functional contamination control teams.
• Thorough, demonstrated knowledge of EU GMP Annex 1, US FDA Aseptic Processing Guidelines, and PIC/S guidelines. 
• Excellent communication in English language is a must.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!