Job Description

POSITION PURPOSE: The Supply Chain and Logistics Quality Operations Associate ensures a high level of compliance with current Good Distribution Practices and Corporate and Canada\'s Policies as well as a timely release of all products, through established quality systems ensuring that all current Health Canada requirements are met. Additionally, provides support for all quality/compliance related matters, as well as through partnering with the Performance and Customer Center of Excellence, Affiliate Quality, Customer Service areas.

RESPONSIBILITIES:
- Ensure maintenance of quality systems aligned in compliance with Quality Standards and Canadian GDP and other applicable regulations.
- Perform Release to Market process to ensure that manufacturing process, specifications, packaging, labeling, validation and the stability program for the products remain consistent with the Product Registration in Canada.
- Ensure the appropriate testing is performed, documentation received and prioritization of product releases is completed as per agreed upon lead times with internal stakeholders (Performance and Customer Center of Excellence, Business Unit, etc).
- Investigations and Deviations: Review and approve deviations and investigations related to supply chain and logistics activities (i.e.: storage and distribution). Assist in assuring improvements of systems and processes are made through CAPA from investigations. Liaison with the Manufacturing Site QA and External Supply QA to ensure proper material status is applied and investigations conducted as appropriate.
- Change Management: Ensure proposed changes have links to all other appropriate quality systems. Partner with Operations to ensure system and process changes are recognized and processed through the Change Control System. Assist with evaluation and implementation plans.
- Suppliers and Contract Service Providers (CSPs) management: Ensure adequate Quality oversight is provided for Logistic Service Providers (LSPs), Transport Service Providers and other SCL related contactors and/ or Suppliers. Assist in the management of external audits.
- Validation/ Qualification: Provide support for the validation and/or qualification program, through review and approval as needed. Provide QA review/approval for LCs and/or LSPs validation protocols and reports (i.e.: facilities, utilities, equipment validations). Ensure periodic revalidation and/or requalification is performed on an appropriate frequency.
- Risk Management: Identify risks and assist in proposing actions for mitigation. Escalate as applicable following process. Complete Risk Assessment Questionnaire of Suppliers and Contractors as applicable
- Escalation to Management: Report any event that may impact quality of the product or regulatory compliance

Qualifications:
- B.Sc. or equivalent in a relevant scientific discipline
- Minimum of 3 years of previous pharmaceutical Quality Assurance experience
- Ability to work effectively with contract manufacturers, technical and non-technical personnel
- Proficiency in using office computer software applications
- Knowledge of Canadian GDP guidelines
- Demonstrated communication and writing skills
- French/English bilingualism is an asset

We thank all candidates for showing interest in this role; however, only retained candidates will be contacted.

For more information on our recruitment services, please visit our website www.groomassocies.com

Votre partenaire en recrutement - Your recruitment partner

Are you interested in this job?

MONTR\xc3\x89AL, TORONTO, VANCOUVER, OTTAWA

HEAD OFFICE

360, St. Jacques, Suite G-100
Montreal (Qu\xc3\xa9bec) H2Y 1P6

\xc2\xa9 2019 Groom & Associates. All rights reserved.

\xc2\xa9 2018 - 2019 Groom & Associates. All rights reserved.

Close

Get in touch

Leave your contact information and one of our recruitment experts will contact you immediately.

Groom Associes