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Quality validation Specialist - Edmonton, AB, Canada - McKesson
Description
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. 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.
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.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.
Contribute to the development and maintenance of training programs to promote validation best practices (requirements in validation, maintenance and use of computerized systems).
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.
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.
Troubleshoot and provide recommendations and solutions for identified validation and qualification issues based upon sound, scientific analysis.
Collaborate to innovatively address Regulatory issues and support achievement of Regulatory Compliance.
Monitoring and communicating performance review, compliance and other metrics updates to key stakeholders.
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.
Use judgment within broadly defined policies and practices.
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.
Support other validation activities as required.
Bachelor of Sciences in Chemistry, Biology or in a related field, preferably with IT knowledge.
3-5 years of work experience in a pharmaceutical/life sciences industry in Validation or Quality.
Preferably 1-3 years experience with computer system validation (CSV) across GxP landscape
Demonstrated experience with Canadian GMP requirements and other applicable regulations/guidelines pertaining to validation of computerized systems and controlled temperature environments.
Experience with development and implementation of qualification and validation programs.
Experience with quality risk management programs.
Experience conducting Quality investigations.
Experience with controlled environment monitoring programs/systems, considered an asset.
Knowledge of regulations and guidelines for temperature control of drug products during storage and transportation.
Strong time management and prioritization skills, with ability to manage multiple projects simultaneously.
Bilingual (spoken/written English and French) considered an asset.
At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people.
The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions.
This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.
The materials on this site are provided without warranties of any kind, either expressed or implied, including but not limited to warranties regarding the completeness of information contained on this site or in any referenced links.
While McKesson attempts to update this site on a timely basis, the information is effective only as of the time and date of posting.
McKesson is an equal opportunity employer and values diversity in its workforce.We encourage applications from all qualified individuals and will accommodate applicants' needs, up to the point of undue hardship, throughout all stages of the recruitment and selection process.
The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.