Technical Group Leader - Flu Downstream Job Toronto area,Ontario Canada,Manufacturing / Production

Reference no: R2866992

Position title:

Technical Group Leader - Flu Downstream (Night) Duration:
Fixed Term Contract - 9 months

Location:

Toronto, ON

About the Job Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. Sanofi Vaccines Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.

Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

Administration of Influenza manufacturing activities Schedule and coordinate daily/weekly work ofa group of technical staff in B200 as per area requirements. Check and review Records, SOP, logbooks/e-logbooks, BPRs/e-BPRs, and monitoring charts for completion and accuracy of all documents as per GMP guidelines. Ensure equipment is kept in good GMP condition (with preventive maintenance, validation and calibration). Order and ensure adequate chemicals, supplies, and spare parts for equipment.

Train and ensure technical staff comply to GMP and SOP requirements. Facilitate daily meetings and report findings to management. Initiate and file deviations and lead investigations. Coordinate and support units within department (Upstream, Downstream, MWS) and other outside departments (Maintenance, Automation, QO test labs, etc.) and ensure timely completion of production activities. Perform other duties as assigned by Department Management throughout all stages of drug substance manufacturing.

Supervise material handling in B200 Shipping, Receiving, and storage areas.

Administration of Data for Influenza manufacturing Coordinate, oversee, and confirm technical staffs completion of SAP activities/transactions. Capacity planning and scheduling of materials and personnel. Create work orders for ETS/Maintenance. Maintain master recipes and production inventory. Create and maintain process orders with authorization to change orders upon demand. Ensure transactions are done in a timely, accurate manner. Oversee and support activities in required environmental monitoring systems.

Ensure all data input is completed accurately and in a timely manner such as investigation data, LIMs, deviation filing, change request forms, etc. Perform activities in PCS and review data as required.

Perform and oversee area specific activities, monitoring, maintenance Perform and delegate production calculations, measurements and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP. Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning. Perform and delegate utility sampling and environmental monitoring as required and ensure completion on schedule.

Train technical staff on problem solving and troubleshooting as required. Ensure area is inspection ready. Knowledgeable to guide inspectors. Perform activities as needed based on access levels on equipment.

Oversight of Health, Safety, and maintenance of GMP environment Train and ensure technical staff comply with HSE requirements. Ensure operators are equipped and use proper PPE when performing tasks. Actively participate in activities done by HSE department and support HSE initiatives. Ensure operations are performed in an ergonomic way and…