Ge Healthcare

Oslo

The Quality Assurance manager - QA systems is responsible for managing the processes associated with Quality Assurance systems, to assure product safety and quality by driving business alignment to cGMP, regulatory &amp; product license requirements and business objectives by managing quality systems, controls and continuous improvements.
Quality Assurance manager - QA systems 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.
Key responsibilities
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Owning the processes associated with the deployment of global policies and site quality procedures. Ensuring quality and site procedures are up to date and reflective of regulatory &amp; industry and GE Healthcare internal standards requirements.
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Responsible for the overall quality risk management at site to assure product quality, patient safety &amp; efficacy.
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Management of the processes of internal and external inspections, including Inspection readiness preparation, inspection execution and ensuring non-conformances are actioned &amp; progressed to closure in a timely manner.
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Responsible for engaging strong intradepartmental and cross-functional / organizational relationships to drive quality system requirements.
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Driving site Regulatory Intelligence processes to ensure timely compliance with Regulatory requirements.
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Influencing site compliance to Quality policy, Quality Management System procedures, regulatory requirements, Product License Requirements and cGMP.
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Responsible for Quarterly Management Review process, analyzing the trend reports, identifying actions / gaps &amp; driving continuous improvements.
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Driving EHS performance in the department in accordance with the requirements of the company’s 5S, safety and environmental management programs.
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Driving GMP training on site.
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Managing and/or support quality programs for Computer Software Validation, Data Integrity and Lifecycle for Analytical Method validation
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Reporting lines:
Quality Assurance manager - QA systems report to the Director of Quality Operations
Required Qualifications
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Master’s degree , preferable within Life Science or Pharmacy.
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Proven track of Quality experience in the pharmaceutical industry
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Proven track of supervisory/management experience
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Experience with regulatory inspections
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Demonstrated experience with regulations in the pharmaceutical industries and knowledge of Quality Management System tools, continuous improvement methodologies &amp; in-depth understanding of site level products &amp; related processes
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Strong oral and written communication skills in both Norwegian and English.
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The role requires physical attendance at the Oslo site
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Required Characteristics
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Strong interpersonal and leadership skills
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Results orientated with a strong ability to effectively troubleshoot, and problem solve issues
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Exceptional planning skills to consistently deliver stretch targets and objectives
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GE HealthCare in Oslo is looking for a new Quality Systems Manager