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.
Reporting to the Sr. Manager Quality, Pharmaceutical Distribution, the Senior Specialist Quality (SSQ), will be responsible for ensuring product or service meets the established standards of quality including reliability, usability and performance. The incumbent will support the central fill and SPS businesses at a regional and/or national level in assurance activities associated with but not limited to equipment validation, temperature monitoring, mapping, , compliance with standard operating procedures (SOPs), and compliance with all Health Canada regulations and associated laws.
At this level, the Senior Specialist Quality typically:
Acts as a key contributor in a more complex/critical environment.
Acts as a resource for colleagues with less experience; may direct the work of others without formal management responsibilities; may utilize internal or external resources to accomplish goals
Develops resolutions to complex problems that require the frequent use of creativity.
Uses judgement within broadly defined policies and practices.
Anticipates change and directs or redirects efforts.
Accomplishes work without considerable direction and exerts significant latitude in determining objectives of assignment.
Anticipates change and communicates with management pre-identified potential solutions
Interacts with senior management and senior customer personnel on matters requiring coordination across organizational lines.
Represents the department on projects and may perform in a project leadership role
Section A - Specific Responsibilities
Certain responsibilities that are typically associated with a job as Senior Specialist Quality are included in Section B. Specific duties generally include but are not limited to the following:
Maintain an adequate level of compliance of the temperature monitoring/pressure program at central fill and SPS at a local and national level
Perform and/or manage:
The execution of the different mapping, equipment qualification, Vaisala installation and programming protocols
Annual probe swap
Verification of the calibration certificates
Acknowledgement of alarms in Vaisala
Deviation writing and problem-solving regarding temperature excursion/system issues
Maintain the outbound qualification program in central fill and SPS facilities at a local and national level
Support pharmacies in identifying the appropriate coldchain and ambient packouts
Execute/manage the qualification of the required coldchain and ambient packouts as per protocols
Perform/manage the routine packout testings as required as per protocols
Deviation writing and problem solving in regard to temperature excursion/packout issues
Track and document the change control related to the temperature management program (packouts, equipments, room)
Support the sites remotely or on site within short term notice as required (10% travelling required)
Serve as a mentor to Quality Site Specialists (QSS) by providing expertise and exhibiting leadership in Quality initiatives
Act as a leader in identifying and/or implementing solutions linked to warehouse and distribution validation activities in collaboration with management, other QSSs and relevant internal and external stakeholders.
Support or lead site quality assessment/self-inspections/client audit as required
Support site in preparation for audits/inspection
National communication of regulatory requirements and/or changes and works closely with the sites to ensure proper dissemination.
Create and dispense training material on Quality topics for a broad range of pre-identified departments
Draft and lead the revision of quality assurance policies and procedures
Support in the interpretation and implementation of the quality assurance standards at a regional and/or national level
Evaluate adequacy of quality assurance standards at a regional and/or national level
Write, review or approve Quality documentation as required (such as but not limited to change controls, deviation report, investigations, validation reports, trend analysis reports)
Collect and compile statistical quality data
Analyze data to identify areas for improvement in the quality system
Prepare reports to communicate outcomes of quality activities
Coordinate or support on-site audits conducted by external providers
Evaluate audit findings, identify risks and implement appropriate corrective actions at a regional and/or national level
Assure ongoing compliance with quality and industry regulatory requirements in regard to qualification, validation and temperature monitoring.
Section B - General Responsibilities
Support the pharmacy sites in all areas related to temperature monitoring program
Promotes understanding of quality standards and processes with the national pharmacy network.
Identify training needs at a national and interdepartmental level and organize training interventions to meet quality standards
Support pharmacy sites in the preparation, execution and follow-up of regulatory inspections by maintaining the inspection file, managing audit documents and response actions.
Section C - Key Requirements
Education and Experience:
B.SC. in Chemistry, Biology or equivalent experience or in a related field.
Knowledge of Canadian drug GMP environment and other applicable regulations pertaining to DIN products, narcotics and precursors.
Experience in Quality investigations, inspection, auditing and testing
Experience with implementation qualification and validation program
Experience in validation, qualifying and temperature monitoring program
Strong computer skills including Microsoft Office, QA applications and databases
Knowledge of the Regulations & Standards of the different Provincials College of Pharmacists
Knowledge of tools, concepts and methodologies of QA
Knowledge of cold chain shipping requirements.
Knowledge of regulations and guidelines for temperature control of drug products during storage and transportation.
5 years of work experience in pharmaceutical industry in Quality Assurance
3 years Experience with equipment qualification/computer system validation (CSV) across GXP landscape
Knowledge and Skills:
Demonstrate strong leadership in a professional environment
Ability to motivate in a teamwork environment
Excellent communication skills - verbal and written
Data collection, management and analysis
Problem analysis and problem solving
Good judgment and decision-making
Capacity to work without considerable direction
Ability to manage time and prioritize tasks is an essential characteristic.
Must be open to 25% travel across Canada.
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.
Join us at McKesson!
Internal Number: JR0044867
About McKesson Corporation
We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare. If you are passionate about combining a meaningful career with a balanced life, join us on this journey and apply for a job with McKesson today. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.