Senior Specialist, Quality Computer Validation (18 month contract)

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Job Summary

The Senior Specialist, Quality Computer Validation supports the validation and ongoing compliance of GxP computerized systems, software, computerized equipment and, where required, controlled-temperature environments. Reporting to the Senior Manager, Corporate Quality Systems & CSV, you will partner with business units, project teams, consultants and service providers to deliver risk-based validation activities in accordance with the Quality Management System, Good Manufacturing Practices and applicable regulatory expectations. You will provide technical expertise, lead validation workstreams and help strengthen reliable, usable and compliant systems across the organization.

Responsibilities

• Lead or support computer system validation and qualification activities across the system lifecycle, including new implementations, upgrades, changes and periodic reviews.
• Author, review and execute validation deliverables, including validation plans, user and functional requirements, specifications, risk assessments, test protocols, traceability documentation and summary reports.
• Prepare and execute installation, operational and performance qualification documentation (IQ/OQ/PQ) for computerized systems, software, equipment and applicable controlled-temperature environments.
• Assess change controls, deviations, investigations and corrective and preventive actions (CAPA), and document validation impact and follow-up actions.
• Ensure regulated project records are complete, accurate and maintained in accordance with the Quality Management System, Good Documentation Practices, GMP and applicable regulatory guidance.
• Coordinate validation activities with cross-functional project teams, distribution centres, external consultants and service providers; communicate status, risks and recommendations to stakeholders.
• Improve validation procedures, quality metrics, training materials and inspection readiness, while providing guidance and mentorship to colleagues with less validation experience.
• Other duties may be assigned as needed to meet Company goals.

Basic Requirements

• Degree or equivalent and typically requires 7+ years of relevant experience.
• Post-secondary degree in science, computer science, information technology or a related field.
• Demonstrated experience executing computer system validation activities in a regulated pharmaceutical, life sciences or similarly GxP-regulated environment.
• Experience authoring and executing validation lifecycle documentation, such as plans, requirements, risk assessments, protocols, test scripts, traceability documentation and reports.
• Experience with change control, deviations or investigations, CAPA and quality risk management within a Quality Management System.
• Working knowledge of GMP requirements and computerized system validation principles, including GAMP 5 and EU GMP Annex 11.
• Experience supporting audits or regulatory inspections as a validation or quality subject-matter resource.
• Experience with ERP systems such as SAP.

Preferred Skills/Experience

• Knowledge of Health Canada GMP requirements applicable to drug wholesalers, distributors or importers, and guidance for temperature-controlled storage and transportation.
• Experience with controlled-temperature environments, monitoring systems, periodic qualification programs or pharmaceutical distribution operations.
• Bilingual communication skills in English and French, and experience coordinating multiple validation projects or third-party suppliers.

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We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position

$99,100 - $132,100

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