
Validation Process Manager
3 days ago
We are seeking an experienced Validation Lead to spearhead the development and implementation of comprehensive validation strategies and processes.
Key Responsibilities:
- Develop, implement, and maintain robust validation strategies and processes that ensure the quality and reliability of products throughout the entire development lifecycle.
- Collaborate closely with cross-functional teams to define validation requirements and priorities, ensuring alignment with organizational goals and objectives.
- Establish, execute, and oversee validation plans, protocols, and procedures in accordance with regulatory standards and industry best practices.
- Lead the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness, accuracy, and adherence to established standards.
- Perform risk assessments and develop mitigation strategies to address potential product risks related to validation.
- Drive continuous improvement initiatives to enhance validation processes, increase efficiency, and improve overall performance.
- Manage relationships with external vendors and contractors as needed for validation testing services, ensuring seamless collaboration and effective communication.
- Ensure end-to-end documentation and traceability of validation activities, maintaining accurate records and providing regular updates to stakeholders.
- Provide expert guidance, coaching, and mentorship to team members, fostering their professional growth and development.
- Ensure training compliance of self and project team members on all customer-related training requirements.
Requirements:
- Minimum 6-12 years of experience in a relevant field
- Strong understanding of regulatory standards and industry best practices
- Excellent leadership, communication, and interpersonal skills
- Ability to work independently and collaboratively in a team environment
- Familiarity with validation methodologies and tools
- Bachelor's degree in a relevant field
About Us:
We are a dynamic organization committed to delivering high-quality products and services. We offer a competitive compensation package and opportunities for career growth and professional development.
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