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Computer System Validation Specialist Jobs

Computer Specialist Jobs
By PCAgent Corp At Greater Toronto Area, Canada

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Computer Specialist Jobs
By Ecole superieur internationale de montreal At Montreal, Quebec, Canada

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Validation Specialist Jobs
By Bora Pharmaceuticals At Mississauga, Ontario, Canada
Prepare, review, and execute Performance Qualifications (PQs) protocols, Bulk Hold protocols, validation/bulk hold summary reports and validation master plans
Uses product and process knowledge as the basis for risk-based validation and continuous verification programs
Interpret and apply QMS and regulatory requirements, updating procedures as required.
Minimum 3-5 years of pharmaceutical experience
Knowledge of GMP, Quality Control, Quality Assurance, Production or Engineering
Able to make informed decisions on validation approach and requirements
Validation Specialist Jobs
By Sectigo At Ottawa, Ontario, Canada
Ability to work with in-house validation and order management tools.
Additional responsibilities and special projects as assigned.
Bachelor’s or college degree in business and/or technical related field or equivalent experience.
2-4+ years of customer support / help desk experience.
Knowledge of Windows and Office products
Experience with information security products. (Antivirus, spamfilter, email encryption, etc.)
Validation Specialist Jobs
By Morson Talent (Canada & USA) At Burnaby, British Columbia, Canada
Performs analysis of system, subsystem and software requirements to define validation methods, and test cases
Develops product knowledge through formal and informal training, OJT, and self-study
Conducts requirement analysis, compliance mapping, and integration/test programme risk analysis
Participates in planning, including participation in the preparation of V&V test plans
Performs integration and test activities in-house and at project sites to mitigate the key project commissioning risks
Performs commissioning tests in plant and at project sites
Computer Systems Validation Associate
By Pharma Medica Research Inc. At Mississauga, Ontario, Canada
Validate new and existing computerized systems for compliance with company SOPs, validation program, and related regulatory requirements.
Develop User Requirements, Test Cases, and Traceability Matrix.
Knowledge of current with applicable (FDA, Health Canada, EU) regulations and guidelines
Post secondary education in a related discipline
3+ years working experience in a related field (i.e., pharmaceutical)
Excellent communication skills including excellent English verbal and written skills
Senior Validation Specialist Jobs
By Think Research At Greater Toronto Area, Canada
Execute other duties as may be required by the site specific management level and other members of the Corporate IT team.
Assess new and legacy systems for compliance with GxP requirements.
Prepare validation plans including qualification protocols (IQ/OQ/PQ) and test scripts for computer systems (Watson LIMS, Analyst Software etc.).
Ensure the site validation program meets FDA and EU requirements as well as GxP guidelines.
Bachelor’s degree in scientific or technical field or equivalent and extensive computer related training courses or experience.
Knowledge of FDA and EU GMP, GCP and GAMP regulations
Technical Staff System Validation Engineer
By Microchip Technology Inc. At Burnaby, British Columbia, Canada
Experience working in a lab environment and knowledge of relevant test equipment and protocol analyzers.
Experience in defining comprehensive test coverage at sub-block and system level, utilizing design specification, feature requirements and industry standards.
Leading complex test execution and conducting investigations in a lab environment on-site and remotely.
Learning and dynamically applying knowledge of the device, system, protocols, and industry standards.
10+ years of relevant industry experience. More junior applicants will be considered for other levels.
Experience leading a small technical team.
Associate Specialist Ii, Validation
By Emergent BioSolutions At Winnipeg, Manitoba, Canada
Possess strong communication and project management skills.
Desirable cGxP validation experience, in the areas of data integrity, installation qualification, operational qualification and performance qualification.
Assist with reviewing User Requirements Specifications, Factory Acceptance Tests and Site Acceptance Tests for facilities, equipment and utilities.
Experience with investigations and root cause analysis principles.
Excellent technical writing and verbal communication skills
Demonstrated ability to manage complex validation projects in a fast paced environment is required.
Process Validation Specialist Jobs
By Resolute Workforce Solutions At North York, Ontario, Canada
Demonstrated leadership in behavioral competencies and project/people management.
Sound knowledge in biochemistry and protein chemistry and raw material experience is an asset.
+ 3 years experience in a GMP biotech pharma/biotech manufacturing, and quality environments in a process validation role.
Good understanding of current regulatory requirements and document preparation.
Process Validation, vaccine manufacturing and batch execution experience required.
Lead process validation team to assure the required discipline for successful execution/completion of deliverables.
Manager - System Validation
By Microchip Technology Inc. At Burnaby, British Columbia, Canada
12+ years of engineering experience with 3+ years in leadership or Management role.
Reporting project status to Director and Project Management Team. Presenting technical information to internal and extern groups
Experience working and leading a team in a lab environment and knowledge of relevant test equipment and protocol analyzers.
Experience in IC, FW and SoC validation.
Experience in defining comprehensive test coverage at sub-block and system level.
Experience in defining and building HW and FW test infrastructure.
Senior System Validation Engineer
By Microchip Technology Inc. At Burnaby, British Columbia, Canada
Experience working in lab environment and knowledge of relevant test equipment and protocol analyzers.
Experience in defining comprehensive test coverage at sub-block and system level utilizing design specification, feature requirements and industry standards
Running complex tests and conducting investigations in a lab environment on-site and remotely.
Learning and dynamically applying knowledge of the device, system, protocols, and industry standards.
5+ years of relevant industry experience. More junior applicants will be considered for other levels.
Experience in IC and SoC validation
Specialist, Computer Validation Jobs
By Taro Pharmaceuticals At Brampton, Ontario, Canada
Minimum 5 years of demonstrated project management experience including project management approaches, tools and phases of the project lifecycle
Experience/Knowledge of supply chain business process is an asset
Strong negotiation, and training skills, required to ensure that quality requirements are maintained while also meeting business expectations
Demonstrated understanding of all quality systems (training documentation change control validation vendor management and internal and external audits)
Recommend corrective measures with the objective of meeting validation requirements when required
Evaluate system(s) changes using a risk based approach and assign appropriate level of validation requirements
Validation Specialist Jobs
By Catalent Pharma Solutions At Strathroy-Caradoc, Ontario, Canada
Prepare and execute validation plans, validation/qualification protocols, validation/qualification reports and study protocols, as appropriate.
Participate in risk assessments to develop validation/qualification approaches.
Experience working in validation within a pharmaceutical manufacturing environment preferred.
Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.
Must be organized and possess good writing skills.
Good computer skills (Word, Excel).
Process Validation Specialist - Diphtheria And Tetanus
By Zany Consulting Group At Toronto, Ontario, Canada
Support Process Validation activities and lifecycle management
Freedom to act, level of autonomy: interface with site management; platform heads, project leaders, global network
Network with local and global experts/ SPPs as necessary, leveraging knowledge/data where possible
Support development and execution tests for SAT and Qualification of CIP skids and their target systems
B.Sc, M.Sc or Ph.D Experience
Minimum 3-5 years direct experience in biotech pharma/biotech manufacturing, and quality environments in a process validation role
Computer Hardware Specialist Jobs
By ITECHXPRT INC. LTD. At Toronto, Ontario, Canada

Depth knowledge of computer hardware and its functionality Depth knowledge about computer, operating system, office 365

Are you looking for an exciting opportunity to join a growing team of Computer System Validation Specialists? We are looking for a motivated individual to join our team and help ensure the quality and compliance of our computer systems. You will be responsible for validating computer systems, developing and executing validation plans, and ensuring that all systems meet regulatory requirements. If you have a passion for quality assurance and compliance, this is the perfect job for you!

Overview:

Computer System Validation Specialists are responsible for ensuring that computer systems used in regulated industries meet the requirements of applicable regulations. They are responsible for the development, implementation, and maintenance of validation plans and protocols, and for the execution of validation activities. They must be knowledgeable in the principles of validation, computer system validation, and regulatory requirements.

How To Become an Computer System Validation Specialist:

To become a Computer System Validation Specialist, you must have a bachelor’s degree in a related field, such as computer science, engineering, or information technology. You must also have experience in the validation of computer systems, as well as knowledge of applicable regulations.

Computer System Validation Specialist Skills:

• Knowledge of computer system validation principles and regulations
• Ability to develop and implement validation plans and protocols
• Ability to execute validation activities
• Knowledge of computer systems and software
• Excellent problem-solving and analytical skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

What is Computer System Validation Specialist Knowledge?

• Knowledge of computer system validation principles and regulations
• Knowledge of computer systems and software
• Knowledge of applicable regulations
• Knowledge of validation tools and techniques
• Knowledge of project management principles

What is Computer System Validation Specialist Responsibilities?

• Develop and implement validation plans and protocols
• Execute validation activities
• Monitor and review validation activities
• Ensure compliance with applicable regulations
• Prepare validation reports
• Provide technical support and guidance
• Troubleshoot and resolve validation issues

What is Computer System Validation Specialist Experience?

• Experience in the validation of computer systems
• Experience in the development and implementation of validation plans and protocols
• Experience in the execution of validation activities
• Experience in the preparation of validation reports
• Experience in providing technical support and guidance

What is Computer System Validation Specialist Qualifications?

• Bachelor’s degree in a related field, such as computer science, engineering, or information technology
• Knowledge of computer system validation principles and regulations
• Knowledge of computer systems and software
• Knowledge of applicable regulations
• Knowledge of validation tools and techniques
• Knowledge of project management principles

Computer System Validation Specialist Education:

• Bachelor’s degree in a related field, such as computer science, engineering, or information technology
• Certification in computer system validation
• Training in computer system validation principles and regulations
• Training in computer systems and software
• Training in applicable regulations
• Training in validation tools and techniques
• Training in project management principles
What tools help Computer System Validation Specialist work better?
• Validation software: Validation software helps Computer System Validation Specialists to develop and execute validation plans and protocols, and to monitor and review validation activities.
• Regulatory databases: Regulatory databases provide Computer System Validation Specialists with access to the latest regulations and standards.
• Project management software: Project management software helps Computer System Validation Specialists to manage their projects and ensure that they are completed on time and within budget.
Good tips to help Computer System Validation Specialist do more effectively?
• Stay up to date on the latest regulations and standards.
• Develop and maintain a validation plan and protocol.
• Monitor and review validation activities regularly.
• Ensure that validation activities are completed on time and within budget.
• Troubleshoot and resolve validation issues quickly.
• Provide technical support and guidance to other team members.
Common Computer System Validation Specialist interview questions?
• What experience do you have in computer system validation?
• What do you know about applicable regulations?
• How do you develop and implement validation plans and protocols?
• How do you execute validation activities?
• What validation tools and techniques do you use?
• How do you ensure compliance with applicable regulations?