Sterility Assurance Quality Compliance Sr. Specialist
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Key skills for this role
About the Role
Acino Pharma seeks a Sterility Assurance Quality Compliance Sr. Specialist to provide end-to-end quality oversight for liquid sterile manufacturing lines. The role owns the site's Contamination Control Strategy (CCS) and ensures alignment with EU GMP Annex 1.
Key Skills for This Role
Responsibilities
- Provide quality oversight for liquid sterile manufacturing lines including aseptic filling and terminally sterilized products
- Own and maintain the site's Contamination Control Strategy (CCS)
- Review and approve Aseptic Process Simulations (APS/Media Fills)
- Oversee microbiological activities including environmental monitoring and product sterility testing
- Conduct gap analyses and risk assessments for Annex 1 compliance
- Design and implement CAPA remediation plans
- Serve as SME during health authority inspections
Requirements
- Experience in sterility assurance and quality compliance in pharmaceutical manufacturing
- Knowledge of EU GMP Annex 1 and contamination control strategies
- Expertise in microbiological methods and environmental monitoring
- Experience with regulatory inspections and CAPA management
Full Job Posting
Role Overview
- Provides end to end quality oversight for all liquid sterile manufacturing lines
- Owns the site's Contamination Control Strategy (CCS)
- Ensures alignment with EU GMP Annex 1 and global regulatory expectations
Key Responsibilities
- Operational monitoring and GxP quality oversight of liquid formulation, sterile filtration, and aseptic filling lines
- Review and approve Aseptic Process Simulations (APS/Media Fills) designs, parameters, and results
- Enforce proper cleanroom behaviors, gowning requirements, and utilities compliance
- Oversee all site microbiological activities including environmental monitoring and product sterility testing
- Author, execute, and update the site wide Contamination Control Strategy (CCS)
- Execute gap analyses and formal Quality Risk Management assessments
- Design, track, and implement CAPA remediation plans
- Partner with production, engineering, and validation teams
- Function as primary SME during health authority inspections
Qualifications
- Experience in sterility assurance and quality compliance in pharmaceutical manufacturing
- Knowledge of EU GMP Annex 1 and contamination control strategies
- Expertise in microbiological methods and environmental monitoring
- Experience with regulatory inspections and CAPA management
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