Senior Auditor, Computer Systems Quality Assurance
Updated: November 28, 2024
Location: Canada (Home-Based)
Job ID: 24006337
Position Overview
Syneos Health seeks a Senior Auditor specializing in Computer Systems Quality Assurance. This role involves planning, conducting, and supporting various GxP quality assurance audits, mentoring junior auditors, and providing expertise in computer system validation audits. This position is essential for ensuring compliance with regulatory standards and maintaining the integrity of computer systems and processes within the organization.
Key Responsibilities
Audit Responsibilities
Internal Audits: Plan, conduct, and close assigned Syneos Health audits, including For Cause audits.
Audit Reporting: Write detailed audit reports and review responses for completeness.
Customer & Regulatory Audits: Prepare for and support customer audits and regulatory inspections.
Leadership and Mentoring
Act as Lead Auditor or Assisting Auditor in team-based audits.
Serve as a trainer and mentor for less experienced QA auditors.
Documentation and Process Improvement
Write, review, or revise QA Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Provide constructive feedback and problem-solving guidance during audits.
Travel
Moderate travel is required (up to 50%) to support global audit activities.
Qualifications
Education and Experience
Bachelor’s degree in science or healthcare-related field (or equivalent).
Minimum of 5 years of experience in GxP quality assurance auditing in the pharma or CRO sector.
Expertise in conducting various audit types (e.g., vendor, process, computer system validation).
Experience with customer audits or regulatory inspections is highly desirable.
Technical Knowledge
In-depth understanding of GxP regulatory requirements with expertise in Computer Systems Quality Assurance.
Familiarity with ISPE GAMP5 concepts preferred.
Proficiency in medical and technical terminology relevant to audit processes.
Skills
Strong organizational, presentation, and interpersonal skills.
Excellent communication abilities, including concise and accurate report writing.
Ability to handle multiple tasks effectively in a dynamic environment.
Cultural sensitivity for effective interaction with diverse stakeholders.
Why Join Syneos Health?
Culture and Growth Opportunities
Career development programs and supportive line management.
Peer recognition and rewards to celebrate contributions.
Commitment to Total Self Culture, fostering inclusion and authenticity.
Benefits
Comprehensive health benefits (Medical, Dental, Vision).
Flexible Paid Time Off (PTO) and sick leave policies.
Eligibility for Employee Stock Purchase Plan and performance-based bonuses.
Global Impact
Join a team that collaborates on groundbreaking advancements in biopharmaceuticals, contributing to the development of life-changing therapies worldwide.
Application Information
Ready to make a difference? Apply today to join Syneos Health or join our Talent Network to stay informed about future opportunities.
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