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
- Strong problem solving skills
- Proven coaching and leadership skills
- Analytical skills
- Thoroughness and Rigor
- Observation skills
- 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.
- Compétent avec MS Office, SAP, LIMS / Competent with MS Office, SAP, LIMS