
Senior Validation Specialist
1 week ago
We are seeking an experienced Senior Validation Specialist to develop and implement validation strategies and processes.
As a key member of our quality assurance team, the Senior Validation Specialist will be responsible for ensuring product quality and reliability throughout the development lifecycle.
Responsibilities:- Develop and implement comprehensive validation plans and protocols.
- Collaborate with cross-functional teams to define validation requirements and priorities.
- Establish validation procedures in compliance with regulatory standards and industry best practices.
- Oversee execution of validation activities, including IQ/OQ/PQ, software validation, and process validation.
- Perform risk assessments and develop mitigation strategies to address potential product risks.
- Drive continuous improvement initiatives to enhance validation processes and increase efficiency.
- Manage relationships with external vendors and contractors as needed for validation testing services.
- Ensure end-to-end documentation and traceability of validation activities.
- Provide regular updates and reports on validation activities to Quality Assurance and senior management.
- Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.
The ideal candidate will have 6-12 years of experience in a similar role and a strong understanding of regulatory standards and industry best practices.
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Senior Software Validation Engineer
1 week ago
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Senior DMPK Specialist
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