Operational Quality Advisor - Nuit Shift

Pharmascience Inc.; Montreal; On-site; CAD 85,000 - 110,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an Operational Quality Advisor responsible for maintaining high quality standards. The role involves conducting audits, managing non-conformities, and ensuring compliance with GMP. Candidates should have a Bachelor's degree in Science and at least 7 years of relevant industry experience.

Qualifications

• Bilingual (French & English) required for documentation.
• 7 years experience in operations in the pharmaceutical, cosmetic, or food industry.

Responsibilities

• Monitor and maintain quality standards by applying GMP and internal procedures.
• Perform internal audits and verify application of GMPs.
• Support audits and assist in non-conformance investigations.

Skills

Analytical skills

Proven coaching and leadership skills

Technical writing skills

Thoroughness and Rigor

Solid organizational skills

Education

Bachelor or better in Science or related field

Job description

Operational Quality Advisor - Nuit Shift

Job Category: Quality

Requisition Number: CONSE003453

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• Posted : May 28, 2025
• Full-Time
• On-site

Locations

Showing 1 location

Description

The Advisor is responsible for monitoring and maintaining high quality standards by applying GMP and internal procedures, tracking KPIs measuring the health of quality systems, and participating in multifunctional SWAT teams to address quality incidents. In case of incidents, they must establish the scope, impact, immediate corrective actions, and the criticality of the investigation, and assist investigators in identifying the scope, impact, immediate corrective actions, and the criticality of deviation investigations. The advisor must review and approve minor and major deviation reports, and ensure the link with other operational services in terms of quality, contribute to establishing and maintaining the quality culture within the operational structure.

Responsibilities:

Operational Quality Management

• Performs internal audits of the production floor and of the reception/sampling activities.
• Verify the application of GMPs, Health & Safety and internal procedures, makes recommendations and manages cases of non-conformity with the responsible personnel involved.
• In cases of non-conformity, participates in determination of immediate action requirements, including lot or partial lot inspections, and lot disposition. Coordinates/ performs inspections.
• Documents actions and lot disposition information electronically in Trackwise and SAP.
• In cases of production non-conformity, actively participates in SWAT discussions and facilitates engagement by cross function team. Represents Quality in the SWAT discussions and ensures correct actions are performed from a quality and compliance point of view.
• Supports investigators of non-conformances and support implementation of effective CAPAs as required Categorizes the quality events and assures immediate actions are identified/adequate and performed.
• Support of audits (client, regulatory, internal) as required.
• Provide guidance and coach, Operational Quality Advisors as well as Operations and QA Investigators.
• Support management of workload related to LIR, Deviation and CAPA systems.
• Monitor, report and ensure the respect of KPIs for Deviation and CAPA systems.

Documentation

• Approve documents related to rework, inspection requests and AQL.
• Prepare samples and submit them to QC laboratories. Enter samples with unique identifier and generate the Certificate of Analysis in LIMS.
• Conducts review and approval of LIRs, minor/ major deviation reports and INF/FOR

QA support to the business

• Actively participate in problem solving and continuous improvement initiatives.
• Prepare and/or participate in training activities.
• Maintain Operational Quality Advisor team tools and files.
• Monitors and ensures respect of departmental KPIs and objectives.
• Supports risk analysis and trending activities to ensure long-term compliance of operational activities with GMP

Skills, Knowledge and Abilities:

• Capacity to take decisions and to communicate them with tact and diplomacy
• Proven coaching and leadership skills
• Analytical skills
• Thoroughness and Rigor
• Solid organizational skills
• Technical writing skills
• Bilingual (French & English) The person will be required to work with suppliers and/or clients located outside the province of Quebec and will be required to read and write documentation in English only.

Qualifications

Education

Required

Bachelor or better in Science or related field.

Experience

Required

7 years:

7 years:

Experience in operations in the pharmaceutical, cosmetic or food industry.