Computer System Validation Specialist Job Openings by Innomar Strategies in Oakville

Job Title Computer System Validation Specialist Job Openings Oakville Innomar Strategies
Pub Date 20 June 2020
Company Innomar Strategies
Location Oakville

Innomar Strategies Hiring 2020 - Innomar Strategies invites the applicant to apply Computer System Validation Specialist, that will be placed in Oakville. You will receive a better prospect as well as less dangerous life sometime soon. Joining to this enterprise makes a people able to do the goal simpler in supplementary to support the current dream be realized.

To help the corporation eyesight and mission comes on legitimate Innomar Strategies is usually open up for brand-new place as July 2020. Everyone who are considering about staffing this specific vacant, you need to take a part in this Computer System Validation Specialist recruitment. If you are one that can certainly fill up requirements, you can look at further info about Computer System Validation Specialist Job Openings below.

Innomar Strategies Jobs 2020

Computer System Validation Specialist Job Openings in Oakville

JOB SNAPSHOT

Employee Type:
Full-Time Location:
Oakville Job Type:
Information Technology Experience:
At least 3 year(s) Date Posted:
6/19/2020

JOB DESCRIPTION

Under the general direction of the Manager, QA Software Testing & Validation, the Computer System Validation (CSV) Specialist is responsible for the implementation of Innomar’s CSV strategy and leading all validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with PIC/S Annex 11 and 21CFR11 requirements is established and maintained at all times. This includes prioritizing, executing, maintaining, and coordination of CSV activities, evaluation of software applications against design specifications and user requirements, and serves as the liaison between the appropriate IT, operational business units and external partners (where applicable) on validation activities, in order to ensure project expectations are properly set and met as per company policies and procedures. The CSV Specialist may occasionally support software/application testing.
What You'll Do:
  • Implement Innomar’s computer system validation (CSV) strategy and lead validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with PIC/S Annex 11 and US-21CFR part 11 requirements is established and maintained at all times.
  • Review and/or assist in developing validation strategies and associated documentation against the requirements of Innomar’s CSV Policy and Procedures, as well as the Validation Master Plan (VMP) to ensure that compliance and business needs are achieved.
  • Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include: Validation Plan, Requirements Trace Matrix, Risk Assessment, IQ/OQ/PQ Testing Protocols, Test Cases, Validation Summary Report, Change control, SOPs, etc.
  • Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
  • Effectively manage all assigned computer validation projects, enhancements, and requests for change (RFCs), including the review of high level estimates (HLEs) from IT/PM to ensure QA timelines provided/forecasted are consistent with the expected project completion date. Complete assigned projects and tasks within agreed deadlines.
  • Design/create and execute test cases (e.g., functional tests, integration tests, challenge tests, regression tests, etc.) and setup data for tests scripts that are appropriate to the risks and purpose of the applications and enhancements.
  • Provide guidance and/or support to other members of the validation team (including operational business units, IT and 3rd party vendors) in the development of validation deliverables, such as User Requirements Specifications (URS), 21CFR11/Annex 11 assessments, Functional Requirements Specification (FRS), Design Specifications, etc.
  • As necessary and where applicable for validated systems, obtain and review Unit Test documentation from the IT development team/vendor to ensure the codes released to the test environment have been adequately unit-tested prior to QA validation activities.
  • Management of defects/deviations/incidents in validation projects, including:
  • Logging all defects/deviations/incidents identified during IQ, OQ & PQ.
  • Organizing defect/deviation/incident Triage Meetings with the required stakeholders to identify resolution – e.g., whether to fix and retest, or defer to a later release.
  • Maintain and update defect/deviation/incident log with appropriate status prior to closure of the project for filing.
  • Coordinate and manage validation and qualification testing documentation review, approval signoff, execution, and post-execution review.
  • Maintain computer system validation documentation and archiving ensuring effective document retrieval when required.
  • Coordinate with IT, QA and applicable business units in the training of validation project team members on testing and validation policies, practices and tools. This may include formal preparation of training materials, one-on-one training, and classroom training.
  • Provide quality guidance and assessment to ensure maintenance of, and changes to, validated systems are managed in accordance with current corporate and regulatory requirements.
  • Conduct QA audits of IT and validation processes as scheduled.
  • Review & provide input, where required, to CSV-related Standard Operation Procedures (SOPs) and/or policies, and ensure adherence to internal SOP’s and regulatory requirements.
  • Keep current with relevant industry and regulatory guidelines.
  • Coordinate and provide direct oversight of third party vendors/partners for all software validation activities assigned.

JOB REQUIREMENTS

Requires a minimum of three (3) years hands-on experience in validation of GxP computerized systems and software development methodologies, preferably in the pharmaceutical, biotech or medical device environment with extensive experience in a matrixed environment and interactions with external vendors. A college or university degree in computer sciences (e.g. IT, information security, engineering, software programming, etc.) is required.

  • Requires formal training in the field of computer sciences (e.g. IT, information security, engineering, software programming, etc.), business administration or similar vocations generally obtained through completion of a four year Bachelor’s Degree program, technical vocational training, or equivalent combination of experience and education.
  • Requires a thorough knowledge and understanding of computer system validation processes and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11and other harmonized international guidelines (PIC/S, ICH) and GxP.
  • Ability to communicate effectively both orally and in writing is a must.
  • Demonstrated understanding of quality assurance and quality systems principles (training documentation, change control, validation, vendor management and audits).
  • Hands-on experience in validation of GxP systems is required.
  • Experience in auditing of IT and validated systems are required.
  • Excellent teamwork and interpersonal skills; leadership and relationship building skills.
  • Strong analytical, problem-solving and conceptual skills.
  • Excellent organizational skills; attention to detail.
  • Ability to resolve system issues effectively and efficiently.
  • Ability to prioritize work load and consistently meet deadlines
  • Practical understanding of project management principles and methodologies.
  • Experience in creation and review of Standard Operating Procedures (SOP’s) is desirable.
  • Experience in using automated enterprise testing tools is an asset in order to support and assist company’s testing initiatives.
  • Experience with one of the following testing tools is an asset: Quality Center, LOADRUNNER, or QUICKTEST PRO.
  • Working knowledge of relevant technology, tools and software; knowledge of UNIX, SDLC, Desktop services, HP Test tools, or equivalent testing tools.


As one of the leading companies in Canada, Innomar Strategies opens variety of opportunities for employees to grow and make them as future leaders of the professional and disciplined. Innomar Strategies also offers a dynamic work environment in order to encourage employees to give optimally, and at the same time, you are able to learn new skills and erudition through the company programs.

If You are interested to submit an application for Computer System Validation Specialist Jobs Oakville July 2020 by Innomar Strategies, please prepare requirements files and documents immediately. To apply by online, please click the "Apply" button below. If you still do not satisfy with a job recruitment above, you can try to read more jobs list in Oakville region from another company below.


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