[Hiring] Global Quality Assurance Auditor @GE HealthCare

Role Description

This role is responsible for providing QA auditing for the Pharmaceutical Diagnostics (PDx) business, focusing on auditing and Global Compliance support to the GMP manufacturing sites and Pharmacovigilance (PV) related functions. Suitable candidates should have experience in the Pharmaceutical industry.

• Perform audits on behalf of CQA with a focus on GMP and PV.
• Share insights and industry trends proactively within the organization to ensure continued compliance and early identification of areas for continuous improvement.
• Provide analyses of audits/trends and support in the assessment and promotion of compliance within PV QA.
• Stay aware of changes to regulations and guidelines, providing support and QA oversight for necessary updates to operating procedures, risk assessments, and change controls.
• Support productivity/efficiency improvement initiatives.

Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma/GED with at least 8 years of experience in the 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.

Requirements

• Support a program (plan, prepare and execute) of internal and external audits for QRA.
• Ensure all identified actions/observations are appropriate to remediate deficiencies and are completed in a timely manner.
• Conduct reviews to ensure effectiveness.
• Work with customers to undertake risk analysis of systems and processes, proposing 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, providing to internal/external stakeholders as agreed.
• Assure completion of vendor qualification and surveillance activities performed and documented as defined in global and functional procedures.
• Participate in quality management system (QMS) improvements.
• Provide guidance and ensure that CAPAs 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 the 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.

Benefits

• Competitive benefits package including medical, dental, and vision.
• Paid time off.
• 401(k) plan with employee and company contribution opportunities.
• Life, disability, and accident insurance.
• Tuition reimbursement.