Job Description
The Role: Our client is a leading pharmaceutical company who is dedicated to delivering high quality products and services. They maintain a high standard across all operations by focusing on compliance, efficiency and innovation. They are seeking a Validation Manager to join the Quality Assurance Department. This person will be responsible for overseeing and managing the Process and Cleaning validation functions on site, ensuring compliance with regulatory standards. And additionally, will coordinate the execution of validation activities (process/cleaning, equipment, and computer qualifications) across various departments. Responsibilities * Contribute to the preparation and review of the Validation Master Plan for Process and Cleaning. * Manage validation requirements for the client, third-party suppliers, and CMOs. * Oversee the preparation, review, and issuance of Validation Protocols and Reports, encompassing equipment, cleaning, process, and computer system validation. * Maintain and oversee the client’s cleaning validation strategy. * Manage the cleaning validation master plan in accordance with EU regulatory standards. * Implement Process Validation for new products to meet regulatory specifications. * Coordinate validation execution with Production, Quality Control, and R&D teams. * Establish, implement, and direct validation and revalidation activities. * Collaborate with contract manufacturing customers to secure approval for protocols and reports as needed. * Identify training needs to support the Validation Department. * Ensure completion of validation protocols and maintain the validation documentation system. * Conduct Internal Audits as required. * Execute Risk Assessments or Investigation reports relevant to the role. * Maintain the validation documentation system. * Report Monthly Validation Metrics on KPIs. * Lead cross-functional teams to resolve technical issues. * Assist in preparing and hosting regulatory and customer audits. Qualifications/Requirements * Minimum qualification: Bachelor of Science/Engineering. * At least 2 years experience in a similar position. * Strong verbal and written communication skills, with the ability to work independently in an analytical environment. * Proficient computer skills, including Word, Excel, and other statistical programs. * Familiarity with Process and Cleaning Validation practices. * Capable of conducting thorough internal audits. * Competent in participating effectively in external audits. * Proven track record of effectively collaborating across functions and communicating with management at all levels. * Demonstrated proactive, motivated, analytical, and strategic thinking abilities. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on (phone number removed)