Quality Coordinator
manufacturing
QualityCoordinator-FillingUnit
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Coordinator - Filling Unit at Quality Coordinator. Skills: quality oversight of the manufacturing, Ensure application of GSK quality systems and cGMP in operations, Ensure regulatory compliance of operations, Manufacturing Batch Record review, Coordinate operational quality tasks and deliverables, Drive inspection readiness activities, Implement and drive strategic priorities, Promote, identify and drive continuous improvement mindset and initiatives. Ensure application of GSK quality sy”
What You'll Achieve.
Ensure application of GSK quality systems and cGMP in operations; Ensure regulatory compliance of operations; Evaluate product impact; Drive inspection readiness activities; Implement and drive strategic priorities; Promote, identify and drive continuous improvement mindset and initiatives; Ensure EHS compliance
Industry & Context.
Demonstrated problem solving and decision-making capabilities; resolve/escalate EHS risks and issues
fixed term contract for 6 months, not opened for relocation
What They're Looking For.
Must Have
Master's degree in an engineering or science discipline, or equivalent experience, Previous experience within a GMP environment (1-3 years), knowledge of cGMP and quality systems, Able to work autonomously, Professional fluency in English and French
Nice to Have
Previous experience in GMP operational roles (such as operations, operational quality, MSAT, logistics), Knowledge of industrial cell culture and/or viral culture, Demonstrated problem solving and decision-making capabilities, communication and influencing skills, Ability to prioritize, manage workload, and escalate issues, Proactively manage personal development (knowledge and skills)
What You'll Do.
Ensure application of GSK quality systems and cGMP in operations (such as deviations
Ensure regulatory compliance of operations and escalate major quality issues and/or compliance gaps
Evaluate product impact and be responsible for quality decisions regarding products/activities in your areas
Ensure adequate shopfloor presence for your area of responsibility
Manufacturing Batch Record review
Coordinate operational quality tasks and deliverables within the team
Drive inspection readiness activities and be the spokesperson during internal and external inspections for your subjects of expertise and areas of responsibility
Implement and drive strategic priorities in your area of responsibility
and be the quality representative in multidisciplinary teams (projects and investigations)
and feedback to peers on quality risks
identify and drive continuous improvement mindset and initiatives using operational excellence tools
Ensure EHS compliance and resolve/escalate EHS risks and issues
How You'll Work.
Team & Collaboration
quality representative in multidisciplinary teams (projects and investigations); Coach, train, mentor, and feedback to peers on quality risks, issues and decisions
Communication Scope
Professional fluency in English and French; communication and influencing skills
Process & Methodology
Implement and drive strategic priorities in your area of responsibility, Coordinate operational quality tasks and deliverables within the team
Full Job Description
**This is a fixed term contract for 6 months** ** _Coordinator, Operational QA, Manufacturing Unit Filling_** An operational role, with the responsibility for quality oversight of the manufacturing within Filling production facility **In this role you will…** * Ensure application of GSK quality systems and cGMP in operations (such as deviations, CAPA, OOS, change control, documentation, validation) * Ensure regulatory compliance of operations and escalate major quality issues and/or compliance gaps * Evaluate product impact and be responsible for quality decisions regarding products/activities in your areas * Ensure adequate shopfloor presence for your area of responsibility * Manufacturing Batch Record review * Coordinate operational quality tasks and deliverables within the team * Drive inspection readiness activities and be the spokesperson during internal and external inspections for your subjects of expertise and areas of responsibility * Implement and drive strategic priorities in your area of responsibility, and be the quality representative in multidisciplinary teams (projects and investigations) * Coach, train, mentor, and feedback to peers on quality risks, issues and decisions * Promote, identify and drive continuous improvement mindset and initiatives using operational excellence tools * Ensure EHS compliance and resolve/escalate EHS risks and issues ** _This job opportunity is a permanent contract _not_ opened for relocation._** **_Why you?_** Qualifications & Skills: * Master’s degree in an engineering or science discipline, or equivalent experience * Previous experience within a GMP environment (1-3 years) and knowledge of cGMP and quality systems * Able to work autonomously * Professional fluency in English and French Preferred Qualifications & Skills: * Previous experience in GMP operational roles (such as operations, operational quality, MSAT, logistics) * Knowledge of industrial cell culture and/or viral culture * Demonstrated problem solving and
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