Global Quality Assurance Auditor, Pharmacovigilance

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $106.4k - $159.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Support a program (plan, prepare and execute) of internal and external audits for QRA. • Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity. • Work with the customer to undertake risk analysis of systems and processes, to propose process / functional audits. • Support regulatory inspections and customer audits as a functional QA subject matter expert. • Conduct trend analysis of audit and other quality related data, provide to internal / external stakeholders as agreed. • Assure completion of vendor qualification and surveillance activities performed and documented as defined in global and functional procedures. • Participates in the quality management system (QMS) improvements. • Provide guidance and ensure that ‘CAPA’s are correctly set up to capture risk assessment, effective corrective and preventive actions and have the required evidence. • Perform QA approvals of Quality Event records. • Keep up to date with latest guidelines from MHRA, FDA, EMEA and other Regulatory bodies. • Monitor legislation, implementing changes, and informing the company of any relevant changes. • Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned.

🎯 Requirements

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 8 years of experience in pharmaceutical industry.) • 6+ years of experience in the pharmaceutical industry • Previous Auditing experience required. • Experience interfacing with global regulatory agencies. • Ability to comprehend and communicate key regulatory requirements and expectations • Experience in collaboration, negotiation & conflict resolution skills • Knowledge of GPvP, cGMP, and GDP

🏖️ Benefits

• medical • dental • vision • paid time off • a 401(k) plan with employee and company contribution opportunities • life • disability • accident insurance • tuition reimbursement