Description
Description
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. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
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).
• Previous experience in supporting customer audits or regulatory inspections in a plus.
• Excellent Knowledge of GxP regulatory requirements with inn 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 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
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health
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. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
