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12 hours ago
As a Senior CQV Trainer, you will play a pivotal role in supporting global regulatory compliance projects remotely. Ensuring adherence to FDA, EU, and other international regulations including GxP standards.
- Lead and execute validation activities for manufacturing equipment, utilities (e.g., HVAC, WFI, clean steam), and computerized systems in accordance with regulatory and industry standards.
- Develop and review validation documentation including User Requirements Specifications, Design Qualification, Functional Performance Qualification, and Installation Qualification documents.
- Manage and implement validation master plans (VMP) and system impact assessments collaboratively with cross-functional teams (engineering, quality assurance, manufacturing, IT).
- Prepare, execute, and lifecycle manage validation documentation for new and existing facilities, utilities, systems, and equipment ensuring seamless integration into capital and remediation projects.
Key responsibilities include preparing and executing comprehensive validation documentation for various assets and systems, ensuring compliance with relevant regulations and industry standards.
Key Requirements- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- 10+ years of hands-on experience in validation and regulatory compliance within the pharma and/or medical device industries.
- Deep understanding of regulatory requirements including FDA, EU Annex 15, ICH Q8-10, ISO 13485.
- Expertise in risk-based validation and GAMP 5.
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Validation Lead
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