GE HealthCare Lead Quality Specialist - Chemistry Systems 

United Kingdom, England 

479412677

As Lead Quality Specialist at GE HealthCare you will have a multifaceted role, ensuring the quality and compliance in the supply of equipment, software and consumables (reagent vial kits and components) for the manufacture of PET radiopharmaceuticals. The role will involve the quality oversight of third party Contract Manufacturing Organisations and suppliers. You will participate in internal, external and customer audits. You will ensure inspection readiness and compliance with cGMP, ISO 13485 and other regulatory requirements by maintaining accurate and up-to-date quality documentation. You will act as the quality representative on projects related to changes, process improvements and new product introduction. You will also provide oversight of local implementation of the global Quality Management System for the business, including change management and handling of customer complaints.
Roles and Responsibilities

• Act as the quality contact internally with Supply Chain, Regulatory Affairs and Commercial in support of the supply of GE HealthCare Chemistry Systems products to the market.

• Act as the quality contact externally, and maintain positive working relationships, with Contract Manufacturing Organisations, suppliers and customers.

• Participate in internal and external audits and inspections and host inspections from customers.

• Ensure inspection readiness and compliance with cGMP and other regulatory requirements.

• Support a Quality culture by driving compliance activities in the development and supply of GE Healthcare Chemistry Systems products. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Execute quality objectives, metrics, reporting and operating mechanisms.

• Provide Quality input to projects, including the development of new products, to ensure compliance with applicable regulatory and quality standards and guidelines and customer requirements.

• Understand products’ critical to quality attributes and apply a risk-based approach in decision making.

• Act as the Quality approver for deviations, CAPA, change control, complaints, validation protocols and reports and product-specific documentation.

Required Qualifications

• This role requires experience in Quality & Life Sciences Quality. Knowledge level is comparable to a degree from an accredited university or college (or a high school diploma with relevant experience).

• Sound knowledge of the pharmaceutical and/or medical device industry

• Sound knowledge of international regulatory, cGXP and/or ISO 13485 requirements

• Experience in performing qualification and routine monitoring audits of suppliers.

• Demonstrated knowledge of quality management systems tools

• Excellent oral and written communication skills and ability to communicate with all levels of the organisation

• Demonstrated effective interpersonal and teamworking skills

Desired Characteristics

• Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

• Familiar with Continuous Improvement methodologies, including Six Sigma

• Familiar with software validation

• Familiar with design control

Total Rewards

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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.