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.