We have other current jobs related to this field that you can find below
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Quality Systems Manager
1 month ago
Exton, United States Zenith LifeScience Full timeQuality Systems ManagerLocation: Exton, PADuration: 12 MonthsJob Description:This position is responsible for maintaining and improving Quality Systems for the Company Americas Region to ensure on-going compliance to applicable compendia, GMP’s, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local...
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Quality Systems Manager
1 month ago
Exton, United States Zenith LifeScience Full timeQuality Systems ManagerLocation: Exton, PADuration: 12 MonthsJob Description:This position is responsible for maintaining and improving Quality Systems for the Company Americas Region to ensure on-going compliance to applicable compendia, GMP’s, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local...
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Contract Quality Systems Manager
1 month ago
Exton, United States Vaco Full timeDescription: This position is responsible for maintaining and improving Quality Systems for the Americas Region to ensure ongoing compliance with applicable compendia, GMP's, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event...
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Contract Quality Systems Manager
1 month ago
Exton, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionDescription:This position is responsible for maintaining and improving Quality Systems to ensure on-going compliance to applicable compendia, GMP's, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event...
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Contract Quality Systems Manager
1 month ago
Exton, United States Frink-Hamlett Legal Solutions Full timeGlobal pharmaceutical company seeks a Contract Quality Systems Manager who will provide Subject Matter Expertise (SME) for Good Manufacturing Practices (GMP) and Data Integrity (DI) requirements by maintaining and improving Quality Systems for the Americas Region. The temporary position is expected to last at least twelve months and the team is located in...
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Contract Quality Systems Manager
1 month ago
Exton, United States Frink-Hamlett Legal Solutions Full timeGlobal pharmaceutical company seeks a Contract Quality Systems Manager who will provide Subject Matter Expertise (SME) for Good Manufacturing Practices (GMP) and Data Integrity (DI) requirements by maintaining and improving Quality Systems for the Americas Region. The temporary position is expected to last at least twelve months and the team is located in...
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Contract Quality Systems Manager
1 month ago
Exton, United States Frink Hamlett Legal Solutions, Inc. Full timeJob DescriptionJob DescriptionGlobal pharmaceutical company seeks a Contract Quality Systems Manager who will provide subject matter expertise for Good Manufacturing Practices (GMP) and Data Integrity (DI) requirements by maintaining and improving Quality Systems for the Americas Region. The temporary position is expected to last at least twelve months and...
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SAP Quality Management Functional Consultant
4 days ago
Exton, Pennsylvania, United States GSSR Inc Full timeJob OverviewKey Responsibilities:Demonstrate a comprehensive understanding of the overarching objectives and operational requirements, leveraging specialized knowledge to collaborate with Quality Assurance and Operations teams to outline detailed User Stories for the digital transformation of business needs. This involves analyzing challenges and proposing...
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SAP Quality Management Functional Consultant
5 days ago
Exton, Pennsylvania, United States GSSR Inc Full timeJob OverviewKey Responsibilities:Demonstrate a comprehensive understanding of the overarching vision and operational requirements while leveraging specialized knowledge to collaborate with Quality Assurance and Operations teams to articulate detailed User Stories for Digital & Technology enablement of business objectives. This encompasses analyzing...
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IT Business Systems Manager
1 month ago
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IT Business Systems Manager
2 months ago
Exton, United States Synerfac Technical Staffing Full timeJob DescriptionJob DescriptionAn industry-leading manufacturer based in Exton, PA, is seeking a seasoned IT Business Systems Manager to join their growing company. This role will be instrumental in maximizing the value of the business IT systems, services, and infrastructure. This position will manage all IT operations, oversee process improvements, and...
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Director of Quality
2 weeks ago
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Director of Quality
2 weeks ago
Exton, United States Medix™ Full timeManagement & OrganizationUphold company's values of Integrity, Excellence, and Respect for People. Ensure employees are well-trained on ethics and compliance policies.Promote a safe and healthy work environment, actively engaging the Quality team in HSE programs and driving improvements toward site goals.Ensure staff qualifications and training, including...
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Quality Engineer
1 month ago
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Quality Inspector
3 months ago
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Quality Inspector
3 months ago
Exton, United States Innovative Solutions and Support Full timeJob DescriptionJob DescriptionOverview: Innovative Solutions Support (IS&S), located in Exton, PA is a diversified international avionics supplier to civil, military, business, and commercial markets. The scope of the IS&S Quality Management System is the design, development, production and repair of Integrated Cockpit Display and Navigation Systems, Air...
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Quality Inspector
3 weeks ago
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Quality Assurance Specialist
4 days ago
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Account Manager
3 months ago
Exton, United States Avanceon LLC Full timeJob DescriptionJob DescriptionDescription:Account Manager / Customer Consultant - Systems IntegrationThe Account Manager plays an integral role in the company’s sales process with an emphasis on the creation of business in assigned accounts. Their focus is to grow accounts and they are measured by closed business based on the plans and needs of their...
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Quality Inspector
3 weeks ago
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Quality Systems Manager
1 month ago
This position is responsible for maintaining and improving Quality Systems to ensure on-going compliance to applicable compendia, GMP's, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local). The role will interface with Quality System personnel in other client sites.
The person in this position will serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements. Must effectively work as a team with internal customers, peers, and management through effective oral and written communication. Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and Data Integrity requirements.
Essential Functions
• Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
• Support external and internal audits for client sites.
• Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for client sites.
• Develop and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.
Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups.
Requirements
Education and Experience
• Bachelor's degree (preferably in science related discipline) preferred
• 5 – 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
• Demonstrated proficiency and experience in working with Quality Systems IT applications
• Training within a regulated Pharmaceutical/biotech/medical device environment
• Understanding and application of CGMP's (EU, JP, US)
• Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum)
Technical
• Strong attention to detail as demonstrated through consistent quality of work
• Excellent written and verbal communication skills
• Computer proficiency in MS Word and Excel, Project and Visio required;
• Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output
• Strong project management skills are preferred
• Ability to anticipate potential problems and take proactive action to avoid/minimize impact
• Anticipates consequences of actions and how they impact other areas
• Ability to independently prioritize, plan and schedule workflow
• Timely follow up to ensure satisfactory resolution to issues
• Knowledge of CGMPs (relevant laws, guidance, directives and industry practice), and demonstrated ability to apply learnings appropriately
• Ability to interpret and apply GMPs, relevant laws, guidance's and directives to extremely complex pharmaceutical situations
• Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency
• Ability to work collaboratively with internal and external team members and customers/contacts
• Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.
• Ability to work in a controlled environment
• Good attendance and reliability
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
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Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.