Senior CSV QA Specialist

Job Summary

The Senior CSV QA Specialist is responsible for planning, executing, and documenting computer system validation (CSV) activities for all business systems that have GxP impact, ensuring compliance with relevant Health Canada and FDA Regulations.

Duties And Responsibilities

• Leads the implementation and maintenance of 21 CFR Part 11, GAMP 5 and related validation and regulatory requirement activities.
• Validates new and existing computerized systems for compliance with company SOPs, validation program, and related regulatory requirements.
• Creates and maintains validation documentation (i.e. Validation Plans, Design Specifications, UFRS, IQ, OQ, PQ, Risk Assessments, Traceability Matrices,Test Scripts, and Validation Reports) for all GxP Systems.
• Designs and executes 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.
• Coordinates and manages validation and qualification testing documentation review, approval signoff, execution, and post-execution review.
• Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
• Carries out periodic evaluations of the GxP systems to ensure conformance with the applicable regulations and performs periodic review / revalidation, as appropriate.
• Maintains computer system validation documentation for all GxP systems and ensures effective documents are readily available, as and when required (e.g.,during audits).
• Follows GxP Computer System Change Control procedures and supports GxP system administration.
• Initiates Quality Events and CAPA plan for any deviations, with focus on eliminating any non-conformances.
• Attends the External Client Audits as the CSV Subject Matter Expert (SME) and addresses any CSV-related queries from the auditors, as needed.
• Supports with CSV Vendor Qualification Questionnaires, as required.
• Collaborates with IT, Quality Assurance, and applicable Business Units to ensure system compliance as well as with outside contractors/vendors to complete validation tasks.
• Prepares CSV guidance documents to educate cross-functional teams on the CSV expectations for GxP Systems.
• Issues strategy recommendations to establish good GxP practices.
• Participate in the evaluation and qualification of IT suppliers.
• Mentors, educates and develops resources within the team.
• Perform other duties as required.
  
  

Qualifications

EDUCATION

• Graduate or post-graduate degree in scientific discipline is required.
• Computer System Validation Certification is required.
  
  

Experience

• 5+ years of hands-on experience in validation of GxP computerized systems (e.g., QMS, DMS, LMS, Inventory Management System, etc.) 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.
• Good understanding of FDA 21 CFR Part 11, GAMP5 and other GxP systems regulatory validation principles and ISO standards to be effective in this position.
• Understanding of data governance and ALCOA++ principles.
  
  

Other Skills And Abilities

• Ability to solve practical problems and deal with a variety of concrete variables.
• Ability to prioritize workload and consistently meet deadlines.
• Ability to work as an individual contributor as well as a team member.
• Excellent cross-functional collaboration with the IT team is a must.
• Excellent communication skills - verbal and written skills
• Exceptional organizational skills and time management.
  
  

Primary Location

ON-Markham