Job Description

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\xe2\x80\x99ll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that\xe2\x80\x99s vital to us all.

Job Summary

Reporting to the Senior Manager, Quality \xe2\x80\x93 Operations & Validation Excellence, the Senior Quality Computer Validation Specialist will be responsible for supporting commissioning and qualification activities for computerized equipment and software systems utilized for various area of the business, ensuring adherence to the established GXP standards of quality including reliability, usability, and performance of the specific systems. The incumbent will support the Operations & Validation Excellence Team and collaborate with various business units requiring quality & validation activities, with the main focus on CSV.

At this level, the Senior Quality Computer Validation Specialist typically:

Interacts with senior management and senior customer personnel on matters requiring CSV coordination across organizational units.

Represents the department on projects and may perform in a project leadership role.

Coordinates activities with CSV project teams, including external consultants and service suppliers.

Supports CSV change control evaluation, investigations, and corrective and preventative action (CAPA) activities.

Assist in the selection and procurement process for new competitive equipment/software.

Co-ordinates with other departments and management teams to optimize validation processes.

Provides technical support and expertise to end users and quality resources.

Acts as a resource and mentor for colleagues with less experience; may direct the work of others without formal management responsibilities; may utilize internal or external resources to accomplish goals.

Supports planning of, and participates in, the execution of the periodic qualification program.

Ensures controlled and/or regulated project documents and records are initiated, advanced, completed and maintained in accordance with the Quality Management System (QMS) and relevant regulatory guidelines, including Good Manufacturing Practices (GMP).

Tracks/monitors and provides timely, accurate information regarding status of tasks.

Section A \xe2\x80\x93 Specific Responsibilities

Certain responsibilities that are typically associated with a job as Senior Quality Computer Validation Specialist are included in Section B. Specific duties include the above and also generally include but are not limited to the following:

Prepare and execute validation deliverables such as commissioning and/or qualification documentation, including installation, operational and/or performance qualification (IQ/OQ/PQ) for computer systems, computerized equipment (automated systems) and cloud-based systems used at McKesson to meet current GMP regulations, industry guidelines & best practice and company policies.

Write and/or review documentation including validation plans, user requirement specifications (URS), functional and design specifications (FS/DS), risk assessment protocols and reports, standard operating procedures (SOPs), CSV training, and others if applicable according to relevant guidelines (e.g., GAMP, 21 CFR part 11).

Maintain key quality metrics and identify improvements.

Draft, and lead collaboration, of quality and validation policies and procedures.

Support the review, interpretation, and evaluation of regulatory requirements and industry best practices.

Manage projects and support initiatives on a DC-specific, regional, or national scale.

Create and dispense training and awareness material on validation-related topics.

Section B \xe2\x80\x93 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 actions.

Practice safe work habits and adheres to company safety/security procedures and guidelines.

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\xe2\x80\x99s policies and practices

Support other validation activities as required.

Section C \xe2\x80\x93 Key Requirements

Education and Experience:

B.Sc/M.Sc or equivalent in sciences or information technologies related field with 3+ years relevant computer experience.

Demonstrated experience in the execution of validation activities within regulated industrial pharmaceutical, information technologies, or life-sciences organizations.

Knowledge of Canadian GMP requirements, CFR Part 11 Guidelines and other applicable regulations pertaining to validation of computerized systems.

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, 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.

Knowledge of project management 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.

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At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That\xe2\x80\x99s why we have a Total Rewards package that includes comprehensive benefits to support physical, 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, please

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

$82,800 - $138,000

McKesson 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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