Knowledge, Skills, and Abilities

• Strong knowledge of EU GMP Annex 11 requirements.
• Good understanding of MHRA Data Integrity Guidance and ALCOA+ principles.
• Knowledge of GAMP5 risk-based validation methodology.
• Understanding of 21 CFR Part 11 (where applicable).
• Knowledge of computerized system lifecycle management in a regulated environment.
• Ability to prepare and review validation documentation (URS, IQ/OQ/PQ, validation reports).
• Strong analytical and risk assessment skills.
• Ability to assess system changes and determine validation impact.
• Strong written and verbal communication skills.
• Ability to manage multiple validation projects and priorities simultaneously.
• Effective cross-functional collaboration skills (QA, IT, Operations, external vendors).
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.

Travel Requirements

None

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Limitations and Disclaimer

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.