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Last updated: 1 day ago
Computer System Validation (CSV) Specialist

Computer System Validation (CSV) Specialist

Innomar StrategiesRemote, ON
CA$150,000.00 yearly
Remote
Full-time
Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...Show moreLast updated: 30+ days ago
Automation (RPA) Developer

Automation (RPA) Developer

Company 1 - The Manufacturers Life Insurance CompanyCAN, Ontario, Télétravail à temps plein
CA$60,000.00–CA$100,000.00 yearly
Remote
Full-time
Group Disability Business Enablement Team.Group Disability and Life teams.This is achieved through collaboration with the business collaborators to understand the business needs, present recommende...Show moreLast updated: 30+ days ago
JPC - 1414 - Senior Project Manager

JPC - 1414 - Senior Project Manager

ITS GlobalOntario
CA$123,500.00–CA$171,500.00 yearly
Our client is looking for a Senior Project Manager to join their team.Strong stakeholder management and ability to work with competing priorities . Ability to understand product and business priorit...Show moreLast updated: 30+ days ago
QA analyst, TSYS

QA analyst, TSYS

Emonics LLCOntario, Canada
CA$65.00–CA$70.00 hourly
TSYS experience, Mainframe file handling, VB scripting , UFT or Selenium.Show moreLast updated: 30+ days ago
Asbestos Analyst

Asbestos Analyst

Paracel LaboratoriesON, CA
Full-time +1
Quick Apply
Who We Are Paracel Laboratories Ltd.Our main laboratory facilities are located in Ottawa and are supported by an environmental lab in Hamilton and microbiology and an asbestos laboratory in Mississ...Show moreLast updated: 12 days ago
Senior Analyst, Quality Assurance

Senior Analyst, Quality Assurance

Ontario HealthOntario Health, Ontario
CA$55,000.00–CA$60,000.00 yearly
Full-time
At Ontario Health, we are committed to developing a strong organizational culture that connects and inspires all team members across the province. Our vision is that together, we will be a leader in...Show moreLast updated: 30+ days ago
  • Promoted
Senior Shopify Developer

Senior Shopify Developer

AkkodisOntario, Canada
Full-time
Mostly if not entirely backend development.The Customer is taking on the front end development responsibilities.So frontend expertise in liquid is not a hard requirement but good for the candidate ...Show moreLast updated: 7 days ago
Senior Product Manager, Staking

Senior Product Manager, Staking

BitgoOntario
Drive the expansion of BitGo’s staking capabilities.Lead and motivate a team of engineers and other cross-functional representatives in building coins infrastructure, DeFi, and wallets for institut...Show moreLast updated: 30+ days ago
Sr. Quality Assurance Auditor GCP GXP

Sr. Quality Assurance Auditor GCP GXP

ParexelRemote, Ontario, Canada
Remote
Full-time
When our values align, there's no limit to what we can achieve.Join Parexel’s team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of ...Show moreLast updated: 29 days ago
Manager Quality Assurance

Manager Quality Assurance

Sotera HealthON, Canada
CA$84,000.00–CA$100,000.00 yearly
Full-time
Reporting to the General Manager, the Quality Assurance (QA) Manager is directly responsible for managing and coordinating all quality functions for the facility. He / She maintains responsibility for...Show moreLast updated: 30+ days ago
QA 6533-19

QA 6533-19

FoilconLa Gran YajaToronto, Ontario, Canada
CA$97,500.00–CA$136,500.00 yearly
HM Note : This hybrid role is two (2) days onsite and commences April 1, 2024.Provides advice on the testing strategy, test plans, the selection of testing tools, and the identification of resources...Show moreLast updated: 30+ days ago
  • Promoted
Software Quality Assurance (QA) Specialist

Software Quality Assurance (QA) Specialist

Graitec StrucsoftOntario, Canada
Full-time
Graitec Innovation Canada (operating as StrucSoft Solutions) is a leader in Building Information Modeling (BIM) framing solutions, offering cutting-edge software tools for the construction industry...Show moreLast updated: 4 days ago
  • Promoted
Performance Tester

Performance Tester

Open Systems TechnologiesOntario, Canada
Full-time
We are seeking a highly skilled and experienced Performance Tester with over 10 years of hands-on expertise in Micro Focus LoadRunner and strong proficiency in Application Performance Monitoring (A...Show moreLast updated: 4 days ago
Construction Supervisor

Construction Supervisor

Agnico EagleOntario-Kirkland Lake-Macassa
Full-time
Reporting to the Senior Supervisor, you will be part of the Construction Department.Construction Supervisor will be responsible for planning, supervising, coordinating and executing construction, l...Show moreLast updated: 1 day ago
Murex - QA

Murex - QA

eTeamRemote, ON
CA$50.00–CA$60.00 hourly
Remote
Show moreLast updated: 30+ days ago
  • Promoted
Manager, Clinical Product Development Quality Assurance

Manager, Clinical Product Development Quality Assurance

Company is ConfidentialOntario, Canada
CA$110,000.00–CA$150,000.00 yearly
Full-time
Manager, Clinical Product Development Quality Assurance.The primary purpose of the Manager, Clinical Product Development Quality Assurance (DPQA) is to lead the communication, facilitation and exec...Show moreLast updated: 7 days ago
  • Promoted
Senior Full-Stack Engineer

Senior Full-Stack Engineer

Motion RecruitmentON, Canada
Full-time
Senior Full-Stack Software Engineer – Remote (Canada) | Full-Time.A fast-growing tech company is seeking a .Senior Full-Stack Software Engineer. In this role, you'll collaborate closely with cross-f...Show moreLast updated: 5 days ago
(Remote) Quality Assurance Analyst

(Remote) Quality Assurance Analyst

N. Harris Computer Corporation - CADOntario, Canada
CA$60,000.00–CA$90,000.00 yearly
Remote
Full-time
NorthStar Utilities Solutions is a leading provider of innovative technology solutions that help utility companies thrive in the digital era. We are currently seeking an experienced and passionate Q...Show moreLast updated: 30+ days ago
Senior Developer

Senior Developer

Arctic WolfRemote, Ontario
CA$115,000.00 yearly
Remote
Full-time
Arctic Wolf, with its unicorn valuation, is the leader in security operations in an exciting and fast-growing industry—cybersecurity. We have won countless awards for our excellence in security oper...Show moreLast updated: 30+ days ago
Computer System Validation (CSV) Specialist

Computer System Validation (CSV) Specialist

Innomar StrategiesRemote, ON
30+ days ago
Salary
CA$150,000.00 yearly
Job type
  • Full-time
  • Remote
Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

PRIMARY DUTIES AND RESPONSIBILITIES :

  • 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.
  • Flexibility to work overtime when required.
  • Comply with all appropriate policies, procedures and safety rules and regulations.
  • Travel up to 10% of the time.
  • Perform other related duties as assigned by QA management.

EXPERIENCE AND EDUCATIONAL 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.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS :

  • 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
  • What Cencora offers

    We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

    Full time