Spécialiste Assurance Qualité, Opérations (Quart de Jour)

Haleon•Montreal, QC

3d•Onsite

About The Position

Haleon is seeking a Quality Assurance Specialist - Operations to join their Montreal (Saint-Laurent) team. This role is primarily responsible for conducting investigations within the Operations sector, focusing on identifying and analyzing root causes of deviations and recommending appropriate corrective and preventive actions. The specialist will also serve as a quality resource for the Operations team, ensuring compliance with GMP and quality standards in all Montreal plant operations.

Requirements

Mastery of French is required for effective communication and adherence to operational and regulatory standards.
Bachelor's degree in Science or Engineering.
A minimum of 5 years of experience in quality assurance systems and/or compliance within the pharmaceutical industry, or a related discipline.
Proven experience in problem-solving and applying process improvement tools.
Excellent oral communication and technical writing skills.
Solid working knowledge of GMP and regulatory requirements.
Ability to communicate with all levels of the company and influence.
Ability to work under pressure and manage multiple priority projects simultaneously.
Cartesian and analytical mindset.
Critical thinking (discernment/judgment).
Recognized leadership and change management skills.
Excellent interpersonal skills and strong organizational skills.
Computer proficiency (Microsoft Office Suite, ERP, Minitab, LIMS, etc.).

Responsibilities

Direct and conduct thorough investigations by determining and examining root causes, and recommending robust corrective and preventive actions to reduce deviation recurrence.
Partner with colleagues in the sector where the investigation took place to ensure completion and identification of root cause and corrective/preventive actions.
Conduct investigations using tools that promote continuous improvement through root cause determination.
Prepare, analyze, and communicate trends resulting from investigations in accordance with established procedures, in partnership with operations.
Serve as the primary quality resource for investigations and GMP-related activities with production personnel, including department heads, supervisors, and operators.
Establish, promote, and maintain compliance with operational standards related to investigations through One Best Way investigation tools and key performance indicators.
Act as a significant stakeholder regarding corrective and preventive actions and their effectiveness for investigations conducted at the plant, providing feedback and proposing systematic approaches to reduce problem recurrence.
Support Zero Defect projects in collaboration with the operations sector to counter trends identified by investigations.
Participate in prevention-focused initiatives (Quality Gemba focus, Audit Readiness Program, corrective and preventive action effectiveness checks, etc.).
Maintain key performance indicators and visual management methods.
Guide the Operations team on GMP.
Conduct investigations system audits to ensure adherence to plant procedures, company guidelines, and One Best Way investigation tools.
Perform any other related tasks (e.g., quality standard gap analysis, etc.) assigned by the Quality Assurance Supervisor.