Conseiller principal en qualité des opérations

The Lead Advisor QA Operations is responsible for monitoring and maintaining high quality standards at the operational level by assuring the adequate application of Good Manufacturing Practices and internal procedures.

He / She is responsible to monitor KPIs measuring the heath of quality systems such as CAPA's and deviations.

He / She actively participates in the multi-functional teams addressing quality incidents. In the case of quality incidents, he / she is responsible for the establishing scope, impact, immediate corrective action and investigation criticality.

He / she supports the deviation investigators with identification of scope, impact, immediate corrective action and investigation criticality as needed.

He / She conducts review and approval of minor and major deviation reports and INF / FOR / WI. He / She interfaces with all other operational departments in matters of Quality.

Above all, the Lead Advisor, Quality Operations contributes to establishing and maintaining the culture of quality throughout Pharmascience’s operational structure.

Responsabilities & Duties

• 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 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.
• Monitor, report and ensure the respect of KPIs for Deviation and CAPA systems

QA Support to 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
• French and English oral & written (client and supplier audits)
• Competent with MS Office, SAP
7 days ago