Sr Auditor, Computer Systems Quality Assurance Updated: September 17, 2024 Location: Latin America-Colombia Job ID: 24004821 Senior Auditor, Computer Systems Quality Assurance Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. Job Responsibilities Syneos Health Audits: Plans and conducts assigned audits. Performs For Cause audits. Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management. Reviews responses to audit findings for appropriateness and completeness. Closes assigned audits. Customer Audits/Inspections: Prepares for and hosts or supports customer audits. Prepares for and hosts or supports Regulatory Authority Inspections. Other: Serves as Lead Auditor on team-based Syneos Health audits. Serves as Assisting Auditor on team-based Syneos Health audits. Serves as a trainer and mentor to less experienced QA auditors. Supervision: Requires minimal instructions on day-to-day work and new assignments. Other tasks: May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs). Performs other work-related duties as assigned. Moderate travel may be required (up to 50%). Qualifications What we're looking for Requires a Bachelor's degree in the science/health care field or equivalent with 5 years experience in GxP quality assurance auditing in the Pharma or CRO sector. Previous experience in the conduct of multiple audit types (e.g. vendors, process, computer system validation). Excellent knowledge of GxP regulatory requirements with in-depth knowledge of Computer Systems Quality. Knowledge of ISPE GGAMP5 concepts is preferred. Knowledge of medical and technical terminology related to the audit types to be conducted. Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency). Able to handle multiple tasks to meet timelines in a dynamic environment. Strong organizational, presentation and interpersonal skills. Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds. Ability to negotiate, problem solve and provide constructive feedback. Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. #J-18808-Ljbffr
