Quality Validation Specialist
6 months ago
McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 12 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But we're so much more than a distribution company. We've automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions. Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all.
At McKesson Canada, you’ll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
**Job **Summary**:
Reporting to the Senior Manager, the Quality Validation Specialist will be responsible for the coordination, tracking and recommendation on the equipment and temperature validation process, as well as computerized system validation process. The incumbent will support any Regulatory inspection.
The Quality Validation Specialist will be responsible for ensuring cGMP compliance of operations and continuous improvement activities are established, monitored and maintained to ensure compliance with all applicable regulations related to validation for McKesson Canada.
**Specific** Responsibilities**:
- 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 mínimal 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,
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