McKesson Document Management Specialist in Ontario, Canada
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 17 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.
As a Documentation Management Specialist, you will be responsible for the development, revision, and distribution of active master documents such as Policies, Quality Standards, Standard Operating Procedures, Guidance Documents and Work Instructions.
The Document Management Specialist will be required to work within the QMS to facilitate alignment across multiple documents and may manage multiple assignments simultaneously that support all business activities for McKesson while ensuring compliance to client requirements, proper workflows and appropriate reviews and approvals.
In this position, the incumbent is required to develop and manage an efficient document architecture that is compliant to company Global, Regulatory, Privacy, Ethics and Compliance requirements, as well as for the retention program (archive and destruction of records) that support all business activities.
Specific duties generally include but are not limited to the following:
Develop and manage a central records management process designed through the lifecycle of document management.
Control the process for authoring, review, approval and subsequent distribution, archiving and destruction of Master GxP Documents (SOPs, GD’s, WI’s, Master Records, Reports and other GxP documents).
Develop and maintain site policies/procedures.
Describe and govern the system to ensure GxP documentation and records are managed in accordance with Global Quality requirements, regulations and GMPs.
Function as the Subject Matter Expert (SME) on applicable Regulations.
Provide technical and regulatory guidance with regard to regulations to internal and external stake-holders to ensure overall quality and compliance.
Create and provide appropriate metrics to identify status of documents (i.e., tracking for status, documents approaching expiration, volume of reviews, review time etc).
Ensure offsite records storage is aligned and managed within the policies and procedures of the document management system and are integrated with the life cycle approach to the GxP-related documents.
Provide subject matter expertise during internal audits and external inspections and audits.
Ensure deployment and implementation process sustainability and effectiveness.
Keep current of updates to applicable Regulations.
Review applicable Change Control Documents to ensure referenced changes are made and are compliant.
Post-secondary education (University degree preferred) in business, operations management, science, engineering or related areas preferred;
Four to six years’ experience and understanding of quality in the pharmaceutical/health care industry
Thorough knowledge of cGMPs, regulatory, privacy and compliance requirements are required.
Ability to work independently and work well with others and must spend a significant amount of time working with the operations team to understand processes.
Advanced knowledge of risk and compliance methodologies and processes. This involves strategizing, planning, managing, writing, and/or reviewing the activities and documents.
Knowledge and competencies in document management software applications and solutions, including experience or training in document management system.
Strong customer focus and ability to prioritize and adapt to business needs.
Ability to communicate and work with a very broad spectrum of professional and technical staff to effectively manage documents and records in an efficient and practical manner.
Experience interacting with regulatory agencies and health authority inspections.
Excellent organizational, interpersonal and leadership/teamwork abilities.
Good presentation and problem-solving skills, and ability to make decisions.
Proven leadership and interpersonal skills;
Ability to communicate and gain commitment at all levels of the organization;
Ability to efficiently present key elements of a project in relation to the audience’s need;
Ability to proof-read, edit with strong technical writing skills
Strong analytical skills and ability to synthesize;
Strong collaboration mindset enabling efficient communication between different groups, departments;
Strong written and oral communication skills.
Ability to work independently and problem solve.
Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.
We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.
But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that 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.
No agencies please.
The material contained herein is provided for informational purpose only. All open jobs offered by McKesson Canada 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.
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By providing your application to McKesson Canada you hereby consent to McKesson Canada obtaining personal information regarding you that is related to the position applied for. You also consent to McKesson Canada transferring your application details to our recruitment partners for their review and assistance. You also consent to McKesson Canada keeping your application on file.
McKesson Canada 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.
Organization: McKesson Canada
Title: Document Management Specialist
Requisition ID: 18006348