Quality Specialist

Summary

Responsible for execution and expertise of many Quality Assurance (QA) activities in Brazil affiliate, ensuring quality and regulatory compliance of a large and multi-modality facility (pharmaceutical and medical devices). Main responsibilities encompass act as Responsible Pharmacist, Batch Release, Complaint Handling, QMS activities and Operational support to Business Projects.

GE Healthcare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health -digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.

• Act as Technical Responsible Pharmacist of GEHC Pharmaceutical Diagnostics (PDx) legal entity, overseeing all technical services and ensuring compliance with current laws and regulations, the quality and safety of products and site conditions. Serves as a liaison between the company, regulatory agencies (such as the Regional Pharmacy Council and ANVISA) and the consumer, ensuring legal compliance and sharing accountability in the event of any irregularities.
• Ensure and support execution of Route Qualification Program.
• Perform batch release and disposition of pharmaceutical and medical devices products. Participate in S&OE meetings to ensure alignment and QA communication.
• Support Medical Devices Labeling (nationalization) pre batch release.
• Oversight of retention samples and warehouse controls (pest, temperature, licenses).
• Support Customers Technical visits and Customer requests to GEHC qualification.
• Act as Complaints Responsible.
• Open, execute, approve and oversight TWD QMS registers (CAPA, Change Management, Non-conformities, Complaints, Investigations and other quality registers to ensure compliance).
• Support investigation of events and complaints related to Illicit Products (stolen, lost, falsified, tampered and any other suspect).
• Execute metrics and support QMR meetings.
• Control GxP trainings / training matrix / training schedule, assign and perform QA trainings to the business.
• Grant access and support to QA electronic systems (TWD/Veeva), act as TWD Administrator and Lead TWD committees.
• Ensure Organizational Charts and s are updated.
• Oversight and periodical review of QMS documentation. Control physical and electronic documentation in PDx EDMS system.
• Support External Audits.
• Open and control purchase orders for QA.
• Support site quality objectives, business priorities and NPI.
• Implement local and global projects related to your area of expertise.
• Participate in external forums and perform benchmarking.
• Contribute to Quality Culture, Quality Metrics and site compliance to Quality policy, QMS procedures and tools, Quality Guidelines and Requirements.

• Bachelor's degree in pharmacy
• 100 PERCENT on-site work
• The workstation is located within the logistics operator, where GEHC PDx has a legal entity
• The employee may be required to work at another branch/location due to future changes in logistical operations, always within the Metropolitan Region of So Paulo

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Relocation Assistance Provided: No
Locations - Location: Itapevi, So Paulo, Brazil, CEP