McKesson Quality & Regulatoy Specialist in Quebec, 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.
This is a 12 month contract.
Review of Certificate of An alysis/ batch/packaging/Certificate of manufacturing records to assure all regulatory and internal requirements for the product quali ty. Included is the verification of calculations, and overall review of documents for cGMP compliance when applicable.
Execution of product release prior to distribution. This involves assuring that all GMP documentation is correct in collaboration with the inspectors and verify finished product count reconciliation.
Completefinishedproductreleaseevaluationincluding; collating,evaluationandfillingofthe following technicaldocuments: Master Documents Batch records, Certificates
Maintaincertificatetemplates,createce11ificatesorapproveasneededforbatchrelease,and send to appropriate parties as required.
Process QA Holds asrequired.
Complete Change Control, CAPA , Complaint and deviation investigation in collaboration with the fabricators.
Manage retained samples storage and destruction in collaboration with the warehouse quality personnel.
Update and maintenance of all Quality documentation logs with current revisions.
Write summary reports and communicates in a timely manner findings related to documentation issues including but not limited to delays in receiving documentation from Contract Fabric ators, deviation investigationsetc.
Responsible for Annual Product Review preparation: maintain calendar and prepare reports as per timelines and initiate approvalstep.
Participate in Quality Complaint: coordinate all activities related to products complaint, forwardthemtoallpartiesinvolvedininvestigation,maintainlogs,andpreparereportsand closure letter tocustomers
Participate in Standard Operating Procedures (SOP) review to ensure revisions are processed, tracked and disseminated asrequired.
Participate in the Self- inspections and audits ofoutsourced manufacturing facilities and supplychain.
Solid understanding ofGMP and Good Documentation Practices in the Canadian environment
Documentation Management and finished product release expertise
B Sc. In Chemistry, Biology or similar
3 years work experience in pharmaceutical manufacturing in a similar type role
Meticulous and detail-oriented
Experience with electronic QMS (Quality Management System) preferred
Excellent written and oral communications skills
Excellent organizational and time management skills with ability to manage several projects at once
Ability to work independently and make decisions based on judgment and integrity
Ability to work well under pressure, in a team based environment
Proficient user of Microsoft Office products
Bilingual (French and English)
Ability to resolve problems and good analytical skills
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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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.
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Job: Distribution Operations
Organization: McKesson Canada
Title: Quality & Regulatoy Specialist
Requisition ID: 18004602