Qualification & Validation Specialist wanted – Radiopharma company - MA
This person will be responsible for the planning, implementation and documentation of qualification and
This person will be actively involved in all aspects of process, utilities,computerized systems, and methods validation, as well as qualification of facilities, production systems and equipment, including planning, implementation, data analysis and reporting
• Perform hands on execution of installation, operational and performance qualifications for equipment facilities and utilities in a GMP environment in accordance with predefined test protocols.
• Carry out validation of production and sterilization processes, analytical methods, computerized systems, and cleaning validations.
• Carry out periodic environmental monitoring of clean rooms, with respect to particulate and microbial contamination.
• Plan, implement and document qualification and validation activities.
• Prepare qualification/validation protocols and documentation, including risk assessments.
• Analyze validation/qualification results and compile data into final reports.
• Establish and maintain the life cycle management of systems, facilities, and equipment.
• Support Quality Assurance in verifying the qualification status of systems and equipment, and the validated status of processes, analytical methods, and computerized systems.
• Support the division managers in the planning of maintenance programs.
• Ensure that issues are comprehensively documented, evaluated and resolved during qualification/validation activities (change control, deviations, etc.).
• Participate in equipment failure investigations, corrective/preventive actions, and equipment
• Work according to the laws, regulations and guidelines concerning qualification and validation.
• Engage in effective communication with immediate supervisor and other personnel within the group as well as outside the department.
• Perform other duties as assigned.
• Bachelor's Degree with and 2+ years validation experience; Associate Degree with relevant experience can also be considered.
• 2+ years of experience in validation of process, computerized systems, utilities, and analytical methods in a GMP regulated environment.
• Experience and familiarity with working in classified and controlled areas such as clean rooms and wearing specialized apparel.
• Working knowledge of GxPs.
• Excellent technical writing and verbal communication skills.
• Basic math and statistical skills.
• Must be people-oriented and a team player.
• Experience with Microsoft Office including Excel, PowerPoint, Word, Project, and Visio.
• Must be able to lift to 50 lbs.