Senior Validation Specialist for KNEAT and Paperless Systems
1 day ago
In this challenging role as a Senior Validation Specialist, you will focus on KNEAT and paperless validation methodologies to ensure regulatory compliance and efficiency in biopharmaceutical operations.
Main Responsibilities:- Develop and Execute Validation Protocols: Design and execute validation protocols for automated systems, including software and hardware components. Ensure that all validation activities are conducted in accordance with industry standards and regulatory requirements.
- Implement KNEAT Principles: Assess and mitigate risks in validation processes using KNEAT principles. Collaborate with cross-functional teams to design and validate paperless systems that meet regulatory requirements.
- Conduct Risk Assessments: Identify and assess potential risks in validation processes, developing strategies to address these challenges in a paperless environment.
- Prepare and Maintain Validation Documentation: Develop and maintain comprehensive validation documentation, including protocols, reports, and deviation logs. Ensure that all documentation is accurate, complete, and compliant with regulatory requirements.
- Provide Training and Support: Train team members on KNEAT and paperless validation processes, providing guidance and support to ensure successful implementation.
We offer a highly competitive salary and benefits package, including opportunities for professional growth and development, a collaborative and innovative work environment, and a commitment to diversity and inclusion.
The estimated salary for this position is $90,000 - $120,000 per year, depending on experience and qualifications.
This role requires strong technical skills, excellent communication and collaboration abilities, and a proven track record of ensuring regulatory compliance and efficiency in biopharmaceutical operations.
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