QA Validation Specialist 

The QA Validation Specialist I plays a crucial role in ensuring that all GMP (Good Manufacturing Practice) equipment, facilities, and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This position collaborates closely with Operations, Quality Assurance, clients, and regulatory bodies to provide scientifically sound, documented evidence that systems and processes perform as intended. The Specialist supports validation activities, serves as a technical resource to junior team members, and helps maintain a compliant and high-quality manufacturing environment.

Key Responsibilities

• Perform QA oversight of validation, qualification, and review activities to ensure GMP equipment, facilities, and systems are continuously maintained in a validated state.
• Schedule and prioritize personal tasks as well as tasks for junior team members under the guidance of the Validation Manager.
• Conduct change control assessments for GMP equipment, facilities, and systems to ensure all validation activities comply with regulatory requirements.
• Develop and review validation protocols and reports, including Installation Qualifications (IQ), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping of controlled storage rooms and equipment.
• Review and approve SOPs, protocols, reports, change controls, deviations, and other quality records, providing strong technical expertise and ensuring compliance with global standards.

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Must-Have Qualifications

• Bachelor’s degree in Science or Technical discipline.
• 2–6 years of work experience in the pharmaceutical industry, preferably in a GMP environment.
• Thorough understanding of Cell and Gene therapy manufacturing equipment, facility systems, and validation procedures.
• Experience with Quality Systems such as Document Management Systems (DMS), Laboratory Information Management Systems (LIMS), Validation and Qualification Management Systems (e.g., Kneat), and Trackwise (Change Control, Deviations, CAPA).
• Strong organizational and communication skills, with the ability to manage multiple tasks and collaborate effectively across teams.