Our company is a leading provider of solutions for the pharmaceutical industry. Human health is our top priority, and we strive to ensure that medications are safe and easy to use around the world. A team of over 4,700 people from more than 60 countries contributes to global healthcare every day. We have manufacturing sites in Europe, North and South America, and Asia.
The position of Global Process Owner for Quality processes related to cleanroom definition, implementation, operation, and maintenance at our company is critical to ensuring regulatory compliance, contamination control, and continuous improvement in our cleanroom environments.
Your Contribution:
* Act as Global Process Owner for the Quality processes related to definition, implementation, operation, and maintenance of cleanrooms
* Provide global guidance for the technical and procedural implementation of a robust contamination control strategy
* Lead global, cross-functional teams to define standards for cleanroom design, maintenance, and continuous improvement in compliance with applicable ISO and GMP guidelines
* Develop and provide regular training on cleanroom practices and foster a culture of responsibility and continuous improvement
* Support the rollout and implementation of cleanroom standards by providing methods and templates for gap assessments of processes and requirements to ensure implementation of a contamination control strategy (CCS)
* Define and enforce gowning requirements and protocols for sterile and non-sterile environments
* Develop and implement global monitoring programs to analyze cleanroom monitoring data and review effectiveness of corrective actions
* Support and aligned qualification/validation of cleanroom facilities, utilities, and equipment, including documentation
* Support local root cause analysis and improvements in case of issues, deviations, or complaints
* Track and assess new/changed regulatory requirements and industry trends to ensure timely implementation and improvements
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