About Us: GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. GE is committed to taking on the world’s toughest challenges. In order to fulfill that promise we rely on a culture of leadership, diversity and inclusiveness. We aim to employ the world’s brightest minds to help us create a limitless source of ideas and opportunities. We believe in hiring talented people of varied backgrounds, experiences and styles…people like you!
Role Summary: The Qualified Person (QP) is responsible under EC law to the regulatory authorities for ensuring that the pharmaceutical products supplied have been manufactured, controlled and distributed in accordance with procedures embodied in the various licenses and in accordance with pharmaceutical Good Manufacturing and Distribution Practice and that in all respects they are safe and suitable for the use for which they have been supplied.
Responsible for the review of batch manufacturing records and the process of manufacture supporting the decision to release product in compliance with all license and GMP requirements.
As Qualified Person, required to review requests to vary the process of manufacture as a result of local events and specify any additional work required in order for product to be safe and efficacious.
Assess existing and proposed facilities and working practices and ensure GMP compliance.
Represent QA on a range of development projects and advise on the adequacy of validation of facilities, equipment and new products/processes, including designing strategies to ensure adequate data is gathered.
Accompany and coordinate regulatory inspections from external bodies.
Support the QA audit function to ensure GMP compliance both within the company and at key suppliers.
Contribute to the development of policy within the QA organization.
Manage and participate in projects as the QA representative to meet business objectives.
Coordinate Product Corrective Action activities and liaise with the regulatory agencies as appropriate in these circumstances.
Operate to the code of conduct.
Maintain up to date knowledge of pharmaceutical legislation and best practice.
Review and approve investigation reports, CAPA, Change Control, Complaints and procedures.
Academic degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry & technology, or biology.
Eligible for nomination as a QP in accordance with 2001/83/EEC.
Relevant experience in the GMP production QA environment within a pharmaceutical company.
Knowledge of the regulatory duties and position of a QP.
Knowledge of sterile products manufacturing (including aseptic processing), including QA requirements associated with this.
Clear, logical thinker, able to understand the patient versus regulatory balance when making a batch sentencing decision.
Confident team player, proactive, energetic, dynamic, resilient.
Excellent communication skills.
Strong interpersonal skills, assertive, able to influence others whilst being sensitive to their views.
Able to relate well with and be credible to people at all levels, from work floor to site directors, and inspectors from Regulatory Agencies.
Able to work under pressure and make sound, timely batch sentencing decisions.
Able to work within an increasingly stringent and complicated business environment.
Enthusiastic and committed to success and continuous improvement.
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