• Serve as a delegate and contributor by providing support, assistance, training and recommendations to the stakeholders and specialists working on computerized systems, equipment and temperature validation
• Contribute to the development and maintenance of training programs to promote validation best practices (requirements in validation, maintenance and use of computerized systems).
• Collaborate with and support the IT department to address Regulatory issues and support achievement of Regulatory Compliance.
• Responsible for the impact assessments regarding change controls (i.e., facilities, equipment and process) that may affect temperature mapping and qualification studies.
• Participate in the review of Health Canada inspection reports as appropriate in relation to validation and qualification questions/issues to ensure responses are submitted to regulatory bodies within their deadlines.
• Collaborate with the Corporate Quality and Compliance Team to monitor ongoing progress and ensure appropriate corrective actions are implemented and effective.
• Develop and maintain GMP related documentation, including but not limited to documentation and remediation of deviations resulting from validations / qualifications, change control process, and qualification protocols. Ensure that Distribution Centers have certified copies of documents from the Corporate Regulatory Team and appropriate signatures are obtained.
• Analyze and provide interpretation on McKesson’s Temperature monitoring system and route temperature profile system to Quality Site Specialists and increase the knowledge base across the National Regulatory Team.
• Develop, write and review validation and qualification protocols, templates and tools on an ongoing basis to ensure regulatory compliance to established internal and external criteria for equipment, cold chain/ambient packaging, computerized systems and premises.

• Execute validation and qualification protocols if needed.
• Review processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Produce validation reports as required including preliminary analysis, final analysis and recommendations.
• Manage and maintain the equipment, premises and computerized systems in a qualified and calibrated state.
• Troubleshoot and provide recommendations and solutions for identified validation and qualification issues based upon sound, scientific analysis.
• Schedule the necessary qualifications/re-qualifications with minimal impact on operational activities as required.
• Collaborate to innovatively address Regulatory issues and support achievement of Regulatory Compliance.
• Provide guidance and knowledge on validation and qualification practices and methods.
• Monitoring and communicating performance review, compliance and other metrics updates to key stakeholders.

General Responsibilities

• Promote understanding of quality standards and processes within the company.
• Identify training needs and organize training interventions to meet quality standards.
• Support DCs in the preparation, execution and follow-up of regulatory inspections by maintaining qualification documents and response CAPAs.
• Maintain Good Documentation Practices.
• Act as a key contributor in a more complex/critical environment.
• Develop resolutions to complex problems that require the frequent use of creativity.
• Use judgment within broadly defined policies and practices.
• Anticipate change and directs or redirects efforts.
• Accomplish work without considerable direction and exerts significant latitude in determining objectives of assignment.
• Anticipate change and communicates potential solutions with the management team.
• Responsible to exhibit professional behavior with internal and external associates that reflects positively on the company and is consistent with the company’s policies and practice.
• Develop KPIs and metrics & support data collection.
• Complete Change Control, CAPA and Deviation processing and investigations as needed.
• Support other validation activities as required.