Job Overview
The role of validation engineer is pivotal in ensuring the quality and compliance of our products. As a key member of our team, you will be responsible for creating and executing validation documentation, as well as coordinating validation activities across various departments.
Main Responsibilities
* Validation Documentation: Develop comprehensive validation plans, protocols, reports, and amendments that meet regulatory requirements.
* Quality Documentation: Generate applicable quality documentation in conjunction with validation activities.
* Cross-Functional Team Collaboration: Liaise with cross-functional teams to provide and drive validation inputs and initiatives into operational activities.
* Vendor Management: Liaise with external vendors for validation plans and requirements.
* Project Development: Develop and manage validation projects, including master validation plans.
* GMP Compliance: Ensure ongoing compliance with Good Manufacturing Practice (GMP) in all practices, recording of events, and processes.
* Risk Assessment: Perform and generate risk assessment documents for regulated processes within the scope of our Quality Management System.
* Audit Participation: Participate and drive quality GMP audits.
Key Qualifications and Skills
* Technical Expertise: Strong understanding of validation principles, GMP regulations, and quality management systems.
* Communication: Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
* Organizational: Proven ability to prioritize tasks, manage multiple projects, and meet deadlines.
* Continuous Learning: Commitment to ongoing learning and professional development in the field of validation engineering.
About Us
We are a dynamic organization committed to delivering high-quality products while maintaining regulatory compliance. Our team is dedicated to fostering a culture of excellence, innovation, and continuous improvement.