
Validation Specialist
1 day ago
We are seeking a seasoned professional to spearhead our validation efforts at Compliance Group Inc.
- Key Responsibilities:
- Develop and implement comprehensive validation strategies and processes to ensure product quality and reliability throughout the development lifecycle.
- Collaborate with cross-functional teams, including development, quality assurance, etc., to define validation requirements and priorities.
- Establish validation plans, protocols, and procedures in compliance with regulatory standards (e.g. FDA, ISO) and industry best practices.
- Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.
- Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation.
- Drive continuous improvement initiatives to enhance validation processes, streamline workflows, 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 stakeholders.
- Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship.
Requirements:
- 6-12 years of experience in validation or a related field.
- Strong knowledge of regulatory standards (FDA, ISO).
- Excellent communication and collaboration skills.
- Ability to lead and manage a team.
Benefits:
- Opportunity to work with a leading company in the industry.
- Collaborative and dynamic work environment.
- Professional growth and development opportunities.
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