Description

Auditor II, QA (Good Pharmacovigilance Practice exp required)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring together talented experts across a broad spectrum of business critical corporate functions. Every role plays an essential part in enabling our customers to achieve their goals. Our teams are agile, collaborative, and committed to delivering—for each other, for our customers, and ultimately for the people who rely on the services we support.

Discover what your 25,000 future colleagues already know:

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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

JOB SUMMARY

Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions (WIs), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs.

Job Responsibilities

General Profile

Syneos Health Audits

Plans and conducts assigned 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.Assists senior QA personnel in hosting or supporting Regulatory Authority Inspections.undefined

Supervision

Requires some instructions on day-to-day work and new assignments.undefined

Other Tasks

Performs other work-related duties as assigned.Moderate travel may be required (up to 50%).

QUALIFICATION REQUIREMENTS (please Indicate If preferred)

Requires a Bachelor's degree in the science/health care field or equivalent with moderate experience in GCP quality assurance auditing. Good knowledge of GCP regulatory requirements.
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 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.

http://www.syneoshealth.com

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.

Summary

Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions(WIs), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs.