Job Description:

• Provide quality compliance oversight to all aspects of validation, principally computer systems validation, and also equipment, process, facility and cleaning validations

• Assure that documented evidence exists to provide a high degree of assurance that the operation and maintenance of all systems are consistently reproducible, meet the required standards and specifications, and all computerized systems comply with laid down requirements

• Review and approve change control requests, validation protocols, validation reports and assure appropriate support documentation is included

• Author, where necessary, computer system validation documents

• Respond promptly to customer needs, resolve technical and tactical operational problems within the scope of the position and draft and/or review documentation such as plans, scripts, and qualification protocols

• Develop metrics to track progress and ensure a strong compliance profile is maintained and maintain all equipment, processes, and computer systems in a validated state

• Develop and maintain system for documentation and record keeping to ensure that change control and access is maintained within compliance

• Maintain systems logs of all equipment processes and computer systems

• Educate Plant, QA and all technical functions in CSV and GAMP5 requirements and develop and maintain CSV SOPs to meet regional and GAMP5 requirements

• Serve as a member of project teams for new equipment, facility upgrades and process validations to ensure Design Qualification has Quality and Compliance input from project initiation to final qualification

• Lead and / or participate in local and regional teams in CSV project initiatives and be the CSV Subject Matter Expert for all FDA, Corporate or other regulatory inspections

• Lead and / or participate in investigations to ensure thorough root cause analysis is conducted and CAPA implementation is effective and sustained

• Audit validation systems and implement corrective actions as necessary.