UDI Printer Validation
Hire IT People, LLC
Job Seekers, Please send resumes to resumes@hireitpeople.com Primary Skills: Experience with validation implementation.
Description:-
Client is seeking Resources to Validate Printer Equipment - Intermec and BELL-MARK printers and LVS barcode verifiers.
Candidate MUST have experience validating printers in Med Dev companies.
-Location: Mansfield MA and 75% travel to other company sites
Job Description
• Develop system validation scripts based on software/hardware configuration for enterprise systems
• Work with facility Subject Matter Experts to document user requirements
• Update application system User Requirements, Functional, and Design Specifications
• Develop Installation Qualifications based on Design
• Develop Operation Qualifications based on functional requirements
• Develop Performance Qualification scripts based on configuration
• Route validation documentation
• Manage Tasks based on aggressive timelines
• Interact with customers at multiple sites
• Interact in team environment
Qualifications
• Experience with validation implementation.
• Minimum BA / BS or relevant work experience in information systems,
engineering, science or business.
• Validation experience with computerized systems in the pharmaceutical industry.
• Excellent oral and written communication skills.
• Strong technical background - familiar with writing queries
• Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice.
• Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
• Ability to work independently with minimal supervision.
• Adhere to timelines
• Quick learner
• Experience with SharePoint
• Expert in MS Word
• Able to multitask
Description:-
Client is seeking Resources to Validate Printer Equipment - Intermec and BELL-MARK printers and LVS barcode verifiers.
Candidate MUST have experience validating printers in Med Dev companies.
-Location: Mansfield MA and 75% travel to other company sites
Job Description
• Develop system validation scripts based on software/hardware configuration for enterprise systems
• Work with facility Subject Matter Experts to document user requirements
• Update application system User Requirements, Functional, and Design Specifications
• Develop Installation Qualifications based on Design
• Develop Operation Qualifications based on functional requirements
• Develop Performance Qualification scripts based on configuration
• Route validation documentation
• Manage Tasks based on aggressive timelines
• Interact with customers at multiple sites
• Interact in team environment
Qualifications
• Experience with validation implementation.
• Minimum BA / BS or relevant work experience in information systems,
engineering, science or business.
• Validation experience with computerized systems in the pharmaceutical industry.
• Excellent oral and written communication skills.
• Strong technical background - familiar with writing queries
• Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice.
• Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
• Ability to work independently with minimal supervision.
• Adhere to timelines
• Quick learner
• Experience with SharePoint
• Expert in MS Word
• Able to multitask
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