Qc Laboratory Instruments and Systems Manager - Toronto, Canada - Sanofi US

Sanofi US

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Reference No. R2669451

Position Title:
QC Laboratory Instruments and Systems Manager

Department:
QC Data Logistics & Support

Location:
Sanofi Pasteur Limited, Toronto

Sanofi Pasteur:
The world's leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.

Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.

Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Position Summary:

This position is primarily responsible for the management of QC equipment and related business functional administrative activities for QC laboratory systems.

The incumbent will work closely with Quality Control, Quality Operations, Engineering Technical Services and Digital to ensure ongoing control and compliance of QC equipment and electronic systems and related data.

The incumbent combines an understanding of cGMP, equipment qualification, equipment decommissioning and lab electronic systems administration. The Equipment Manager position reports directly to the Deputy Director of Laboratory Management / Data Logistics and Support (DLS).

Key Responsibilities:

Equipment qualification, decommissioning and support (65%)

Coordinates equipment qualification activities with QC labs and relevant supporting functions such as QOVS, QOOQ, ETS, Digital.
Ensure completion of necessary documentation/deliverables reflecting qualification of QC equipment.
Coordinates and leads execution of equipment decommissioning process for QC equipment.

Electronic System administration and support (10%)

Performs business administration relating to qualified QC electronic systems (master data configuration, user support requests) for systems such as Caducee/Empower, LabX, SoftMax Pro, MassHunter.
Performs business administration relating to electronic systems (SDMS).

Quality systems and documentation (10%)

Reviews existing SOPs and initiate revisions/approvals of existing or new SOPs, protocols, reports and test summaries as required.
Responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews.
Manages activities related to Change Control and CAPA, as required.

Support responses to internal and external audits as required (10%)

Compile data to support regulatory submissions, audits, and root cause analysis as required.
Accountable to ensure the timely filing, and completion of all GxP documents associated.

Training/skills upgrade/literature review (5%)

Complete onthejob training according to current lesson plan. Attend and participate in required training sessions continually.
Support and comply with all Sanofi Pasteur health, safety and environmental policies, contribute toward meeting departmental goals; and demonstrate progress in preventing or reducing injuries and/or illness.

Scope and dimensions:

Breadth of responsibility (global/regional/country/site): Site
Key dimensions: Key dimensions include shop floor quality/compliance adherence, management/scheduling of operational and project activities. This is a salaried position with no direct reports that will give guidance to both salaried and nonsalaried personnel across the site. The position liaises with QC Laboratory Management, SQO, ETS and Digital as required.
Freedom to act, level of autonomy: The incumbent interprets cGMPs and industry guidance and is responsible for making decisions to improve the quality and compliance status of QC equipment and associated data in context of equipment qualifications and operations. He/she makes decisions on the initiation and implementation of continuous improvement projects. Responsible for the interpretation of cGMPs and industry guidance to achieve the required compliance levels.

Key Requirements:

Preferred of bachelor's degree in Science or Engineering
Require a minimum of 35 years of manufacturing industry experience (preferred industries in chemicals, pharmaceuticals, food, beverage, or oil/gas)
Strong technical background in manufacturing, process and specifications
Must be a selfstarter, detailoriented, effective independent contributor, and work well in t