Spécialiste Assurance Qualité, Opérations (Quart de Soir)

Haleon•Montreal, QC

3d•Onsite

About The Position

Haleon is a manufacturing site for health products in liquid, solid, and semi-solid formats, with complex regulatory factors, technical processes, and high-risk activities. Haleon is currently looking for a Quality Assurance Specialist - Operations to join the Montreal (Saint-Laurent) team. The Quality Assurance Specialist - Operations is primarily responsible for conducting investigations in the Operations sector, continuously seeking to effectively determine and analyze the root causes of deviations, and recommending appropriate corrective and preventive actions. The Quality Assurance Specialist - Operations also serves as a quality resource for the Operations team, ensuring compliance by maintaining GMP and quality standards in all activities related to the Montreal plant's operations.

Requirements

Mastery of French is required for this position to ensure effective communication and compliance with our 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 in a related discipline that will enable the team to meet its mission.
Recognized 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 simultaneously manage multiple priority projects.
Cartesian mindset and analytical skills.
Critical thinking (discernment/judgment).
Recognized leadership and change management skills.
Excellent interpersonal skills and a very good sense of organization.
Computer skills (Microsoft Office suite, ERP, Minitab, LIMS, etc.).

Responsibilities

Leads and conducts thorough investigations by determining and examining root causes, and recommending robust corrective and preventive actions to reduce the recurrence of deviations.
Works in partnership with colleagues in the sector where the investigation was conducted to ensure its completion and that the root cause and corrective and preventive actions are identified.
Conducts investigations using tools that promote continuous improvement by determining the root cause of the problem.
Works in partnership with operations to prepare, analyze, and communicate trends resulting from investigations in accordance with established procedures.
Serves as the primary quality resource for investigations and GMP-related activities with production personnel, including department heads, supervisors, and operators.
Establishes, promotes, and maintains compliance with operational standards related to investigations through One Best Way investigation tools and key performance indicators.
Acts as a significant stakeholder regarding corrective and preventive actions and their effectiveness for investigations conducted at the plant, provides feedback, and proposes systematic approaches to reduce problem recurrence.
Supports Zero Defect projects in collaboration with the operations sector to counter trends identified by investigations.
Participates in prevention-focused initiatives (Quality Gemba focus, Audit Readiness Program, corrective and preventive action effectiveness checks, etc.).
Maintains key performance indicators and visual management methods.
Guides the Operations team on GMP.
Conducts investigations system audits to ensure adherence to plant procedures, company guidelines, and One Best Way investigation tools.
Performs any other related tasks (e.g., quality standards gap analysis, etc.) assigned by the Quality Assurance Supervisor.