Quality Assurance (Qa)- Computer System Validation
By Assurea LLC At United States
Work closely with CSV management for validation activities and implementation timelines
Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements
Efficient and skilled in writing documents / formatting / understanding Microsoft office and able to create templates etc.
***Required GCLP computerized systems validation and R&D experience
Provide QA support for CSV deliverables and ensure internal procedures and regulations are met.
Perform gap assessment of current computerized systems procedures and policies to ensure applicable regulations are met.
Computer System Validation Engineer/ Csv
By Tech Aveev LLC At Nashville, TN, United States
variety of personalities, discipline skills and educational levels.
•Manage URS and FS, updating customer comments / review cycles.
•Must have a minimum of 4 years in the medical device industry/GMP experience.
. •Experience with Automation equipment for device assembly and testing.
•Knowledge of GAMP (Good Automated Manufacturing Practices) GMP and GDP.
• Demonstrate Excellent interpersonal skills with an ability to interact well with a
Senior System Validation Engineer
By INTEL At , Hillsboro
OR - Master of Science degree in Electrical/Computer with 5+ years of relevant experience
OR - PhD in Electrical/Computer with 2+ years of relevant experience
In certain circumstances the work model may change to accommodate business needs.
Computer System Analyst Jobs
By Varmoda Tech At Ashburn, VA, United States
Working knowledge of proposal development and capture management for Federal customers
Work as a part of the pre-sales team to provide technical solutions for customer requirements.
Apply principles of CMMI, ISO 9001:2018, ITIL V4, and CMMC to develop the concept of operations to meet technical requirements.
Recommend tools and technologies to meet customer requirements
Develop features and benefits for the technical solution and represent them in complex technical diagrams
Knowledge of Software Development Lifecycle
Senior System Analyst Jobs
By Revature At California, United States
************Experience with Insurance (HealthCare) Finance ; especially Capitation********
Strong software logic design, analytical/analysis and problem solving skills
Ability to effectively document all requirements, solution designs and functionality.
Domain knowledge in application cloud integration and technologies
Ability to work in a remote matrixed team structure and maintain positive attitude
Experience with Agile frameworks and in developing Use Cases or User Stories a plus
Senior System Analyst Jobs
By Revature At United States
************Experience with Insurance (HealthCare) Finance ; especially Capitation********
Strong software logic design, analytical/analysis and problem solving skills
Ability to effectively document all requirements, solution designs and functionality.
Domain knowledge in application cloud integration and technologies
Ability to work in a remote matrixed team structure and maintain positive attitude
Experience with Agile frameworks and in developing Use Cases or User Stories a plus
Computer System Validation Consultant
By Vakula Technologies Inc At New Jersey, United States
Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
Background and experience in AGILE SAFE methodology.
Experience in the Pharmaceutical, biotechnology, or medical device industry
3 to 7 years experience in Computer System Validation
Experience in FDA and/or Global regulated environment with a good understanding of GxP standards and Risk-based validation.
Knowledge of FDA guidance and industry standards (i.e., GAMP)
Senior System Analyst Jobs
By lululemon At Columbus, Ohio Metropolitan Area, United States
10+years of work experience in information technology with solid experience working on Manhattan warehouse management systems, preferably WMOS
Knowledge and experience with distribution center automation technologies such as warehouse control systems (WCS), material handling equipment (MHE), Putwalls, Autobaggers, etc.
Excellent communication and interpersonal skills with a proven ability to work under pressure and during critical production issues
Solutions to business issues or requirements
Drives partnership with fellow team members to share knowledge, documentation, and alignment to new solutions
Acknowledge the presence of choice in every moment and take personal responsibility for your life.
Computer System Validation Supervisor
By Catalent At , Bloomington, 47403, In
You will assist in the oversight of qualification activities for all capital expansion projects.
You will assist with audits for validation/qualification documentation.
Years of leadership experience, 3+ years preferred
Year of GMP experience, 3+ years preferred
Competitive medical benefits and 401K
Catalent offers rewarding opportunities to further your career!
Senior Validation Specialist Jobs
By POINT Biopharma At Indianapolis, IN, United States
Experience in project management, test design, process flow, and troubleshooting.
5+ years relevant experience in validation and GMP.
Proficiency in manage multiple projects, setting priorities, and working in a fast-paced environment.
Experience using precision measuring instrument and electronic testing devices.
Excellent oral and written communication skills
Excellent organizational and interpersonal skills
Senior System Analyst Jobs
By Paragon Cyber Solutions (8a, EDWOSB, VOSB, C3PAO-Candidate) At Vandenberg Air Force Base, CA, United States
Collaborate with internal and government stakeholders to assure system designs comply with requirements/best practices
Minimum of five (5) years of experience in network communications.
Experience designing and implementing network infrastructures in secure environments
Knowledge of Internet Protocols, communication protocols, data and network security
Experience working with design principles and applications
System and network device scripting experience, preferred
Senior System Analyst Jobs
By Resolvit At Durham, NC, United States
5+ years systems analysis experience; related work in software solutions definition/development is required
Confirmed experience with systems development methodologies and formal documentation processes.
Experience analyzing mainframe systems such as COBOL, db2, distributed applications, cloud based, oracle, etc.
Strong data analysis skills including querying, profiling, analyzing, and validating data.
Financial Services experience is preferred.
Strong analytical, facilitation and communication skills including written, verbal, and technology illustrations.

Are you looking for an exciting opportunity to use your computer system validation skills? We are looking for a Senior Computer System Validation Analyst to join our team and help ensure the quality and compliance of our computer systems. You will be responsible for developing and executing validation plans, protocols, and reports, as well as performing risk assessments and audits. If you have experience in computer system validation and are looking for a challenging and rewarding role, then this is the job for you!

Overview:

A Senior Computer System Validation Analyst is responsible for ensuring that computer systems used in the healthcare industry meet all regulatory requirements. This includes validating the accuracy and reliability of the system, ensuring that the system meets all applicable standards, and providing guidance on system design and implementation.

Detailed Job Description:

The Senior Computer System Validation Analyst is responsible for validating the accuracy and reliability of computer systems used in the healthcare industry. This includes performing system design reviews, developing validation plans, executing validation tests, and documenting results. The analyst will also provide guidance on system design and implementation, and ensure that the system meets all applicable standards and regulations.

What is Senior Computer System Validation Analyst Job Skills Required?

• Knowledge of computer systems and software validation processes
• Ability to analyze and interpret data
• Excellent problem-solving and communication skills
• Knowledge of applicable regulations and standards
• Ability to work independently and as part of a team
• Ability to manage multiple projects simultaneously

What is Senior Computer System Validation Analyst Job Qualifications?

• Bachelor’s degree in Computer Science, Information Technology, or related field
• 5+ years of experience in computer system validation
• Knowledge of applicable regulations and standards
• Experience with software validation processes
• Knowledge of system design and implementation

What is Senior Computer System Validation Analyst Job Knowledge?

• Knowledge of computer systems and software validation processes
• Knowledge of applicable regulations and standards
• Knowledge of system design and implementation

What is Senior Computer System Validation Analyst Job Experience?

• 5+ years of experience in computer system validation
• Experience with software validation processes

What is Senior Computer System Validation Analyst Job Responsibilities?

• Perform system design reviews
• Develop validation plans
• Execute validation tests
• Document results
• Provide guidance on system design and implementation
• Ensure that the system meets all applicable standards and regulations