Senior Auditor, Computer Systems Quality Assurance Specialist
11 hours ago
Syneos Health is seeking a highly skilled Senior Auditor, Computer Systems Quality Assurance to join our team. As a key member of our quality assurance team, you will be responsible for planning and conducting audits, ensuring compliance with regulatory requirements, and providing expert guidance to our clients.
Key Responsibilities- Plan and conduct audits to ensure compliance with regulatory requirements
- Develop and implement audit plans, procedures, and protocols
- Conduct For Cause audits and write audit reports
- Review responses to audit findings and ensure completeness and appropriateness
- Close assigned audits and ensure timely completion
- Prepare for and host or support customer audits and regulatory inspections
- Lead team-based audits and provide guidance to less experienced auditors
- Develop and maintain knowledge of regulatory requirements and industry standards
- Bachelor's degree in a science or healthcare field or equivalent
- 5 years of experience in GxP quality assurance auditing in the Pharma or CRO sector
- Previous experience in conducting multiple audit types, including vendors, processes, and computer system validation
- Excellent knowledge of GxP regulatory requirements and computer systems quality
- Knowledge of ISPE GAMP5 concepts and medical and technical terminology
- Strong organizational, presentation, and interpersonal skills
- Cultural sensitivity and ability to communicate effectively with diverse stakeholders
Syneos Health offers a competitive salary range of $67,700 to $115,100, a company car or car allowance, health benefits, a 401(k) plan, and opportunities for professional growth and development.
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Montreal, Quebec, Canada Syneos Health Full timeSyneos Health is a leading fully integrated biopharmaceutical solutions organization. Our mission is to accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. As a Senior Auditor, Computer Systems Quality Assurance, you will play a critical role in ensuring the...
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Montreal, Quebec, Canada Syneos Health Full timeSyneos Health is a leading fully integrated biopharmaceutical solutions organization. Our mission is to accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. As a Senior Auditor, Computer Systems Quality Assurance, you will play a critical role in ensuring the...
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Senior Auditor, Quality Assurance Specialist
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Montreal, Quebec, Canada Syneos Health Full timeAbout Syneos HealthSyneos Health is a leading biopharmaceutical solutions organization that accelerates 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 we do. We are...
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