Quality validation Specialist
Edmonton, Canada Job ID JR0109935 Category Quality Assurance Post Date Apr. 16, 2024McKesson 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 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.
Key Requirements
Education and Experience:
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.
Strong computer skills including Microsoft Office and databases.
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 and Skills:
Knowledge of current regulations and best practices, including, but not limited to, GMP, PICs, Annex 11, GAMP 5.
Strong knowledge of Health Canada's GMP Regulations including those applied to wholesalers and distributors/importers.
Knowledge of regulations and guidelines for temperature control of drug products during storage and transportation.
Knowledge of validation tools, concepts and methodologies.
Strong analytical skills, excellent interpersonal, written & oral communication skills.
Good judgment and decision-making.
Ability to work independently with minimal direction
Ability to act as a SME during internal and external audits.
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. That’s why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, pleaseclick here.
As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
Our Base Pay Range for this position
$74,900 - $124,800McKesson is an Equal Opportunity employer.
The material contained herein is provided for informational purpose only. All open jobs offered by McKesson on this recruitment system are subject to specific job skill requirements. 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.
Current employees must apply through internal career site.
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