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Role Summary: GE Healthcare Ireland Ltd. manufactures & distributes X-ray and MRI Contrast Media for internal and external customers worldwide. In 2016, our production volume was ca 27.7 mill units (vials) and supported turnover across the Supply chain of ~USD 500M. As part of our ongoing journey to achieve our 2020 site vision of being a 50m unit (vials) capacity site we have created this new role to drive the necessary cultural and operational transformations and simplifications to make this happen.
Essential Responsibilities: The QA Manager (Production) is responsible for managing and providing leadership to the QA Production team of QP’s, QA Specialists and QA analysts, as well as liaising closely with the Production Manager in the Cork Site to deliver the customer and business needs in a compliant manner that enhances the direct relationship culture. The QA Manager (Production) will engage with the relevant support departments and build strong relationships with same.
You will demonstrate Role Model Leadership by facilitating, coaching, mentoring and developing your team. You will deliver EHS performance in accordance with the requirements of the company’s 5S, safety and environmental management programs.
The QA Manager (Production) reports to the Director of Quality Operations.
Key responsibilities/essential functions include:
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 lead the Production 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
Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business
As part of the QA Management Team responsible for driving the Quality goals in support of the overall business objectives
Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice
Achieve key project deliverables on time and in budget and support Ad Hoc projects as and when required.
Develop and maintain critical relationships with support departments to both develop the role and to enable the growth of the site
Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organisation
Excellent communication and negotiation skills promoting openness, dialogue and collaboration
Results orientated with a strong ability to effectively troubleshoot and problem solve issues
Exceptional planning skills to consistently deliver stretch targets and objectives
Act as a change agent to promote a culture of continuous improvement
Qualifications/Requirements: Desired Skills and Experience:
Proven Years’ experience within a regulated environment. v3rd level qualification in Science / Engineering discipline
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 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 organization.
Experience in developing strong working relationships across teams and functions.
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