Senior Specialist, SAP Validation - Brockville, 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. 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, Corporate Validation, the Sr. Specialist, SAP Validation & Support will be responsible for leading validation activities and post-implementation support for SAP S/4 Hana and ensuring adherence to the established GxP standards of quality including reliability, usability, and performance of the specific systems. The incumbent may also be required to support the Quality Operations & Validation Excellence Team and collaborate with additional business units requiring quality & validation activities.

At this level, the Sr. Specialist, SAP Validation & Support typically:

• Interacts with senior management and senior customer personnel on matters requiring validation-related coordination across organizational units.
• Represents the department on projects and may perform in a project leadership role.
• Coordinates activities with project teams, including external consultants and service suppliers.
• Supports change control evaluation, investigations, and corrective and preventative action (CAPA) activities.
• 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.

Specific Responsibilities:

• Act as a liaison with Business Representatives to provide awareness of the validation deliverables, expectations, and regulatory commitments.
• Build project validation plans and timelines, in conjunction with Business Representatives, for the preparation, execution, and reporting of validation deliverables for SAP S/4 Hana, including support to, and alignment with, Business Representatives on documentation.
  • Deliverables include, but are not limited to, risk and compliance assessments, User Requirements, Functional Requirements, System Design/Configuration Requirements, Validation Plan, IQ/OQ/PQ Test Plans & Scripts, and Validation Summary Reports.
• Drive/support validation-related/validation-impacting issue resolution in collaboration with Business Representatives.
• Maintain key quality metrics and identify risks and improvements throughout project phases, including post-implementation.
• Draft, and lead collaboration, of quality and validation policies and procedures, as requested.
• Support the review, interpretation, and evaluation of regulatory requirements and industry best practices.
• Create and dispense training and awareness material on validation-related topics, as applicable.

General Responsibilities:

• Promote understanding of quality standards and processes within the company.
• Identify training needs and organize training interventions to meet quality standards.
• 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's policies and practices
• Support other validation activities as required.

Key Requirements:

Education and Experience:

• B.Sc/M.Sc or equivalent in sciences or information technologies related field.
• 7 -10 years experience in the execution of validation activities within regulated industrial pharmaceutical, information technologies, or life-sciences organizations.
• 5+ years experience in regulatory validation and post-implementation support of SAP S/4 Hana.
• Experience with development and implementation of qualification and validation programs.
• Experience with quality risk management programs.
• Experience conducting Quality investigations.

Knowledge and Skills:

• Knowledge of current regulations and best practices, including, but not limited to, GMP, PICs, Annex 11, GAMP 5.
• Knowledge of Canadian GMP requirements and other applicable regulations/guidelines pertaining to validation of computerized systems and controlled temperature environments.
• Knowledge of validation tools, concepts and methodologies.
• Knowledge of project management tools, concepts and methodologies. (PMP designation an asset)
• 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 deliverables 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 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 click 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

$84,500 - $140,800

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.
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