Overview of Validation Lead Role
The role of a Validation Lead is crucial in ensuring compliance with regulatory standards and internal quality policies. We are seeking a skilled professional to oversee the planning, coordination, and execution of validation activities within our organization.
Key Responsibilities
* Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports in accordance with regulatory and industry standards.
* Lead validation efforts for critical equipment, facilities, and systems.
* Collaborate with cross-functional teams to define and execute validation requirements.
* Maintain knowledge of applicable regulations and ensure validation activities align with them.
* Identify and resolve validation-related issues, providing risk assessments and remediation plans as needed.
* Oversee the development and training of the validation team, ensuring high standards of competency and compliance.
* Provide technical validation support for tender processes, including preparing and reviewing validation documentation as part of bid submissions.
Required Skills and Qualifications
* Relevant Engineering Qualification (Level 7 or Level 8 Mechanical)
* Minimum of 5 years working in a Lead role within a regulated environment
* Experience in a GMP manufacturing environment
* Proficient in Microsoft Office (Excel, Word, PowerPoint)
* Excellent communication and decision-making skills
* Team player with flexible approach
* Competent level of technical writing and understanding of technical documentation
About Us
We are a specialist in cleanroom validation, commissioning & compliance, working with our people to implement and carry out maintenance and asset management to optimize performance.