Spécialiste LIMS QC

Haleon•Montreal, QC

1d•Onsite

About The Position

Haleon is currently seeking a LIMS QC Specialist to join the Montreal (Saint-Laurent) team. As the LIMS QC Specialist, you will be responsible for acting as the LIMS system expert within the Quality Control laboratories. You will support daily QC operations by providing technical support, troubleshooting, and training to ensure the continuity of analyses and the proper functioning of the system. You will participate in or lead projects related to LIMS initiatives, play a key role in change management, and ensure all activities comply with corporate Quality standards, internal policies, site procedures, and regulatory requirements (e.g., FDA). You may also interact with regulatory agencies during audits concerning QC activities and LIMS usage.

Requirements

Proficiency in French is required for this position to ensure effective communication and compliance with our operational and regulatory standards.
Technical diploma or Bachelor's degree in science, such as chemistry, biochemistry, microbiology, pharmaceutical sciences, or a related field.
Minimum of 5 years of experience in the pharmaceutical industry, ideally within a QC laboratory environment.
Understanding of regulated environments, including the expectations of agencies like the FDA, and the ability to apply strict procedures.
Ability to work independently while effectively managing priorities in a demanding operational setting.
Strong problem-solving skills, particularly in the context of LIMS system support and QC operations.
Bilingualism, required for interacting with internal, external, and above-site teams.

Nice To Haves

Knowledge or experience with LIMS, particularly StarLIMS.
Experience in a pharmaceutical or regulated environment beyond the minimum requirement.
Hands-on laboratory experience with electronic systems, analytical software, or connected instruments.
Mastery of Data Integrity requirements related to QC operations.
In-depth knowledge of regulatory requirements, including documentation, compliance, system validation, and audit readiness.

Responsibilities

Ensure LIMS training and support within the QC department to guarantee the continuity of laboratory operations and the functionalities necessary for material release testing.
Collaborate with internal and external partners to successfully complete projects according to established plans, both locally and at the corporate level.
Manage and analyze data: user access management, specifications, calculations, static data, and testing.
Work with above-site teams to ensure LIMS modifications or updates are deployed in QC and aligned with network needs and desired efficiency gains.
Support, participate in, or lead initiatives related to the validation of electronic systems used in QC departments.
Play a key role in change management for all LIMS initiatives.
Ensure all activities comply with corporate Quality standards, internal policies, site procedures, and regulatory agency requirements.
Participate in interactions with regulatory agencies during audits concerning QC operations and the LIMS system.