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General Electric Quality Specialist – Cell & Gene Therapy (m/f) in Eysins, Switzerland

Role Summary:This role will be reporting to the site QA leader in Eysins and will be in Eysins (Nyon), Switzerland.

The QA Specialist will support the Eysins manufacturing site in compliance with the QMS requirements and according to local procedures. The role owner will be responsible for managing complaints and will become the site professional for sterilizations and biological assessments.

Essential Responsibilities:

  • Responsible for complaint handling, reporting, trending and driving the local

  • Complaint Handling team (CHU team)

QA surveillance and approval of sterilization processes and biological assessments

  • Daily batch review and product release

  • QA support of local R&D team and approval of local new product development (NPI) work

  • Support of Risk Management file activities

Document Management: Supporting the site QA leader in maintaining and improving the Cell Therapy and site Quality Management System (QMS)

  • Support of the internal audit process

  • Review and approval of product and process validation

  • Comply with good documentation practices

  • Comply with and support local Quality policy and local EHS regulations

  • Support utilization of GEHC LS quality system metrics such as complaint resolution, corrective and preventive action (CAPA) and training metrics including input for trending and follow-up actions

  • Support other QA/RA key activities as assigned to by the site QA leader

  • Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).

Qualifications/Requirements:

  • Bachelor’s degree in technical or business field or equivalent professional experience

  • One year of experience preferably in regulated medical device industry

  • Effective oral and written communication skills in French and English language

  • Familiar with CAPA systems

Experience with (EO) sterilization process of medical devices

  • Familiar with customer & internal audits

Experience in risk management, design controls, design verification and validation activities

  • Experience in change controls

Desired Characteristics:

  • Experienced in using word processing, spreadsheet, and presentation software

  • Analytical & problem-solving skills/ root cause

analysis

  • Ability to interface with local leadership and internal and external customers, responding in a professional manner

  • Ability to prioritize activities

  • Accepting constructive criticism and dealing calmly and effectively with high-stress situations

  • Excellent interpersonal, organizational, communication skills

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.comAdditional Locations:Switzerland;Eysins;

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