3PL Quality Assurance Specialist ( 12 month contract) @ McKesson

Job Information

Job Description:

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 client manuals and client notes
Provides support during audits as required
Provides assistance with completion of complaint investigations, deviations, change controls, CAPA
Prepares and updates SOPs and WIs as required
Works on special QA projects, including Quality oversight for secondary packaging and labelling
Supports other members of the team as needed
Other tasks as required

General Responsibilities

Maintain relevant industry knowledge and completes required training as required
Act as a McKesson ambassador of corporate values

Position Requirements

Minimum 2-3 years of experience in Quality Assurance in the pharmaceutical industry or a similar role
University Degree (Post graduate degrees and Health Professional degrees are preferred)
GMP training
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
Proficiency with computer applications such as Word, Excel, PowerPoint, and Outlook
Excellent scientific knowledge
Ability to interpret complex Regulatory documents such as Health Canada guidance documents in order to provide guidance to internal and external stakeholders
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

Benefits:
Experience Level: Mid-Senior
Work From: Onsite