Job Description Summary

As the Quality Assurance Specialist/Qualified Person, you 'll manage and drive the site QA systems in conjunction with other Specialists in the QA Product Quality team, coordinate all QA duties relating to QP batch release and communicate all issues relating to batch release schedule in a timely manner to schedule, manage and deliver the batch release schedule in compliance with Regulatory requirements and GMP guidelines. You'll also proactively identify and implement industry best practices including but not limited to internal processes that support manufacturing, quality control, materials management, validation and quality assurance.

Job Description

Responsibilities

• Responsible for coordination of the certification of finished product batches to the market as required under the EU Directive 2001/83/EC

• Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing authorization

• Ensure that all necessary production and quality control documentation has been completed and endorsed by authorized staff

• Maintain oversight of deviations and change controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required

• Pro actively participate in the QMR process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required

• Continuous improvement of the quality systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective

• Maintain knowledge and understanding of quality oversight for services and operations which are outsourced to CMO's / contract labs

• Ensure Quality Managers are appraised on all Quality related issues

• Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business

• Responsible for driving the Quality goals in conjunction with the QA Management team in support of the overall business objectives

• Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice

Qualifications and Experience

• Significant experience within a regulated environment.

• 3rd level qualification in Science / Engineering discipline or equivalent

• Eligibility to act as a Qualified Person in line with local and EU directives

• Self-starter with good motivational, decision making, planning, project management and communication skills.

• Good level of knowledge of Quality, safety regulations, manufacturing and process automation.

• Excellent interpersonal skills with the ability to work effectively with staff at all levels across multiple functions of the organisation.

• Experience in developing strong working relationships across teams and functions.

Eligibility requirements

A good level of English and a valid work permit

Inclusion and Diversity

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.

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.

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Additional Information