Quality Specialist

3 weeks ago

Mississauga, Canada McKesson Canada Full time

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.

**Job Summary**

This position is responsible for ensuring that services within McKesson Biopharma & Provider Solutions business operate in accordance with GxP standards and meet all the requirements of the clients.

The Quality Specialist will be required to work within the Quality Management System (QMS) to facilitate alignment across multiple documents and may manage multiple assignments (including deviations and CAPA) 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 may include the following (dependent on assigned work stream)**
- Control the process for authoring, review, approval and subsequent distribution, archiving and destruction of GxP Documents (SOPs, GD’s, WI’s, Reports and other GxP documents).
- Develop, maintain, and review policies/procedures in the QMS.
- Conducts root cause analysis and evaluation of CAPAs for non-conformances to procedures.
- Conducts analysis and prepares metrics reports on compliance with quality management systems (i.e., tracking document status, documents approaching expiration, volume of reviews, review time, training completion, etc), as well as status of deviations and CAPA.
- participate in scheduled self-inspections in accordance with applicable SOPs and WIs, Issue internal audit reports and follow up on CAPAs/commitments.
- Assist with external audit preparations. Assist with preparation of CAPAs following receipt of audit report.
- Ensure offsite records storage for Quality Department documentation 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.
- Review applicable Change Control documents to ensure referenced changes are identified and are compliant.
- Regularly monitors and evaluates activities to identify potential risks and non-compliances.
- ** Section B**

**General Responsibilities**
- 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.
- Makes continuous recommendations for procedural improvements and problem solve to improve procedures by providing recommendations.
- Keep current of updates to applicable Regulations.
- **
Section C**

**Competencies**
- 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 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.
- Advanced 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 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 bet

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