
Product Validation Expert
3 days ago
Job Opportunity
We are seeking a skilled Validation Specialist to oversee the quality and reliability of products throughout their development lifecycle. The selected candidate will be responsible for developing and implementing validation strategies and processes, collaborating with cross-functional teams, and establishing validation plans, protocols, and procedures in compliance with regulatory standards and industry best practices.
Main Responsibilities:
- Validation Strategy Development: Develop and implement comprehensive validation strategies to ensure product quality and reliability.
- Collaboration: Collaborate with cross-functional teams to define validation requirements and priorities.
- Validation Planning: Establish validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
- Execution Oversight: Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation.
- Risk Assessment: Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation.
- Continuous Improvement: Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
- Vendor Management: Manage relationships with external vendors and contractors as needed for validation testing services.
- Documentation: Ensure end-to-end documentation and traceability of validation activities.
- Reporting: Provide regular updates and reports on validation activities to senior management and stakeholders.
- Team Leadership: Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship.
- Training Compliance: Ensure training compliance of self and project team members on all customer-related training requirements.
Requirements:
- Experience: 6-12 years of experience in validation and quality assurance.
- Regulatory Knowledge: Strong knowledge of regulatory standards (FDA, ISO, MHRA) and industry best practices.
- Leadership Skills: Excellent leadership and communication skills.
- Teamwork: Able to work independently and collaboratively in a team environment.
About Us:
The company is a leading provider of compliance solutions, committed to delivering exceptional results through expertise and innovative approach.
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