Job Title: Sterility Assurance Lead
At our company, we are seeking a highly skilled and experienced professional to lead our sterility assurance program. The successful candidate will be responsible for ensuring the highest levels of contamination control, process integrity, and regulatory compliance.
Responsibilities:
* Developing Comprehensive Sterility Assurance Frameworks: Develop and implement comprehensive sterility assurance frameworks, including contamination control strategies aligned with Annex I and global GMP guidelines.
* Oversight of Environmental Monitoring Program: Manage and optimize the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks.
* Liaising with Cross-Functional Teams: Collaborate closely with Quality, Manufacturing, Engineering teams to ensure alignment on sterility assurance requirements.
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