Quality Specialist, Master Control - Mississauga, Canada - McKesson Canada

McKesson Canada

Verified Company

Mississauga, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

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 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.

Work From Home with fewer fixed days in the office (2300 Meadowvale Blvd, Mississauga)

Job Summary

The Quality Specialist works within Master Control to facilitate alignment and mange 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 that support all business activities.

As a Quality 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 Quality 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.

Section A

Specific Responsibilities
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 stakeholders 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 GxPrelated documents.
Create and/or disable Master Control accounts for those business units supported
Creation of configuration documents (and training as required)
Importation of new documents as required
Creation of tracking reports
Provide training and/or troubleshooting of the system to users
Create and provide appropriate metrics to identify status of quality system tasks (ie. tracking for status, documents approaching expiration, volume of reviews, review time, training completion etc)
Ensure deployment and implementation process sustainability and effectiveness
Support additional system validation efforts brought on by system changes; upgrades and addons

Section B

Requirements and competencies

Requirements:

Postsecondary education (University degree preferred) in business, operations management, science, engineering or related areas preferred;
One to Four years of experience and understanding of quality in the pharmaceutical/health care industry
Knowledge of cGxPs, 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
Advance knowledge of risk and compliance methodologies and processes. This involves strategizing, planning, managing, writing, and/or reviewing the activities and documents
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 intera