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

Experience Level: Mid-Senior
Work From: Onsite

Company Information

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