Validation Specialist for Computer Systems

1 month ago

Oakville, Ontario, Canada CB Canada Full time

Are you passionate about ensuring the integrity of computerized systems in a healthcare environment? At CB Canada, we foster a collaborative and innovative culture focused on enhancing patient outcomes. Our commitment is to promote healthier futures through effective system validation.



Key Responsibilities:

PRIMARY DUTIES:

  • Lead the implementation of CB Canada's computer system validation (CSV) strategy, overseeing validation activities for both hardware and software systems that impact GxP compliance, ensuring adherence to relevant regulatory requirements.
  • Collaborate in the development of validation strategies and documentation aligned with the organization's CSV policies and Validation Master Plan (VMP), ensuring that both compliance and operational needs are met.
  • Prepare comprehensive validation documentation packages, including the creation and execution of essential validation and qualification documents such as Validation Plans, Risk Assessments, and Testing Protocols.
  • Assess changes in validated systems through a risk-based approach, determining the necessary validation requirements.
  • Manage all assigned validation projects, ensuring that timelines and expectations are met while coordinating with IT and project management teams.
  • Design and execute test cases tailored to the risks and objectives of the applications, ensuring thorough validation.
  • Provide support and guidance to team members in developing validation deliverables, including User Requirements Specifications and Functional Requirements Specifications.
  • Review Unit Test documentation from development teams to confirm adequate testing prior to validation activities.
  • Oversee the management of defects and incidents in validation projects, including organizing meetings to address and resolve issues.
  • Maintain and update validation documentation, ensuring effective retrieval and compliance with regulatory standards.
  • Coordinate training for validation project team members on testing and validation practices.
  • Conduct audits of IT and validation processes to ensure compliance with internal and regulatory standards.
  • Stay informed about industry and regulatory guidelines relevant to computer system validation.
  • Manage relationships with third-party vendors involved in software validation activities.
  • Adhere to all company policies and safety regulations.
  • Travel may be required as part of the role.
  • Perform additional duties as assigned by management.


Qualifications:

EXPERIENCE AND EDUCATIONAL BACKGROUND:

Minimum of three (3) years of hands-on experience in the validation of GxP computerized systems, preferably within the pharmaceutical or biotech sectors. A degree in computer sciences or a related field is required.

SKILLS AND KNOWLEDGE:

  • Formal training in computer sciences or related fields, typically obtained through a Bachelor's Degree program or equivalent experience.
  • In-depth knowledge of computer system validation processes and regulatory requirements.
  • Strong communication skills, both verbal and written.
  • Understanding of quality assurance principles and practices.
  • Proven experience in GxP system validation and auditing.
  • Excellent teamwork and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Exceptional organizational skills and attention to detail.
  • Ability to manage multiple priorities and meet deadlines.
  • Familiarity with project management principles is beneficial.
  • Experience with creating and reviewing Standard Operating Procedures (SOPs) is an asset.
  • Knowledge of automated testing tools is advantageous.


What CB Canada Offers:

We provide a competitive compensation package along with a comprehensive benefits program designed to meet the diverse needs of our associates.



Work Schedule:

Full-time position.

Equal Employment Opportunity:

CB Canada is dedicated to equal employment opportunities for all individuals, without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other protected class.



Accessibility Policy:

CB Canada is committed to fair and accessible employment practices and will accommodate individuals with disabilities during the recruitment and employment processes.

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