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Job Summary

Reporting to the Sr. Manager, 3PL and QA Consulting (MSD) , the Sr. Quality Specialist provides support to the department in the management of quality operations.

Section A – Specific Responsibilities

• Responsible for review of all batch release documentation and temperature data to support product release in Canada for MSD imported products/QA consulting clients, including MRA/non-MRA drugs and medical devices

• Review of stability protocols/reports, media fill studies, APQRs, and preparation of APQR addendums

• Responsible for review of receiving documents, scanning and submitting to clients, and final release in warehouse management system following release from client

• Main QA contact for clients assigned to him/her, and responsible for all GMP activities required to support client with ensuring GMP compliance

• Provide Quality Assurance guidance and support to potential new clients or new products as assigned

• Responsible for preparation and update of  quality assurance agreements and client notes

• Provides support during external and internal audits as required

• Provides assistance with completion of complaint investigations, deviations, change controls, CAPA

• Prepares and updates SOPs and WIs as required

• Act as Quality team subject matter expert for new client meetings, specifically pertaining to 3PL and drug importation activities.

• Works on special QA projects, including Quality oversight for secondary packaging and labelling

• Supports other members of the team as needed

• Act as a delegate to the Sr. Quality Manager position where directed

• Other tasks as determined by the Sr. Quality Manager.

Section B – General Responsibilities

• Maintain relevant industry knowledge and completes required training as required

• Act as a McKesson ambassador of corporate values

Section C – Position Requirements

Working Experience

• Minimum 7 years of experience in Quality Assurance in the pharmaceutical industry or similar role

Education

• University Degree (Post graduate degrees and Health Professional degrees are preferred)

• GMP training

Personal Development and Soft Skills

• Ability to work independently and as a member of a team.

• Excellent written and verbal communication skills

• Able to manage multiple projects and deadlines

• Ability to identify compliance risks

Technical Skills

• Proficiency with computer applications such as Word, Excel, PowerPoint, and Outlook

• Excellent scientific knowledge

• Experience working within electronic Quality Management Systems (eQMS) and Warehouse Management Systems  (WMS), specifically SAP

• Ability to interpret complex Regulatory documents such as Health Canada guidance documents in order to provide guidance to internal and external stakeholders

• Experience with AI tools such as Microsoft Co-Pilot is an asset.

Other Skills and Capabilities

• Ability to multi-task and to work in a fast-paced environment

• Attention to detail

• Strong organizational skills

• Strong troubleshooting skills

• Strong time management skills.

#LI-JT2

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position

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