Position Title Sys. Qualif. Qual. Associate (12 months)

Job ID	133099BR
Division	Sandoz
Business Unit	Sandoz - Product Develoment
Country	Canada
Work Location	Montreal South Shore – Boucherville
Company/Legal Entity	Sandoz Canada
Functional Area	Development & Medical
Job Type	Full Time
Employment Type	Temporary
Job Description	Choosing Sandoz, a healthy decision. Located in Boucherville, Québec and counting over 850 employees, Sandoz Canada is one of Canada’s fastest growing pharmaceutical manufacturers. Our plant in Boucherville is one of the largest sterile pharmaceutical manufacturing plants in Canada. Our vision We will be the main provider of high quality, affordable medicines helping secure long-term access to healthcare for people around the world. We will lead our industry, outperforming the market. We will bring the care and passion our employees have for their work to our customers, patients and communities. Join the Sandoz Canada Team! Due to significant investments in Boucherville’s facilities, several new positions are currently opened. Recognized for your leadership and expertise, your commitment to quality and customers and also you are confortable and challenged in a fast paced environment, come join our team. We are currently looking for a Quality Associate, Systems Qualification (12 months). The Quality Associate, Systems Qualification (12 months) ensures compliance to the quality systems (self-inspection program, change controls, training program) and the System qualification (laboratory, equipment, facilities). The Quality Associate maintains and performs trend analysis of the key quality indicators. He(she) contributes to the corporate documentation implementation and participate to the corporate and authority inspections. Summary of tasks: Ensure compliance of Development Systems: Laboratory Instrumentation (Analytics, Stability, Validation), IT Systems (e.g. LIMS, OpenLab, Stability,...), Manufacturing equipment, facilities and warehouses; QA Review and approval of: “system/equipment related“ SOPs for Development Center, qualification documentation, deviation and failure investigation in course of qualification and calibration activities, equipment and facility change control process ; Provide QA release of Systems for GxP or regulatory use (i.e software, equipment, …) Ensure reliability of data and the e-compliance at the SDC Support and approval of e-compliance activities of the computerized systems ; Prepare the plan for all areas in SDC Perform the self-inspection; Monitor the implementation of CAPAs; Manage the change controls process; Maintain and perform trend analysis of KQI; Manage training programs; Manage continuous GMP training program of personnel and current trends specific to SDC Ensure compliance of laboratories responsible for testing regulatory and clinical batches Monitor compliance of SDC labs involved in validation, transfer and stability testing; Monitor compliance of testing lab for regulatory and clinical batches (3rd party); Contribute to the corporate document implementation; support QCM for corporate audits and authority inspections Perform gap assessments for GOPs, Quality Manual modules; Support the implementation of GOPs and Quality Manual modules; Contribute to the preparation of corporate audits and authority inspections; Monitor the implementation of CAPAs of corporate audits and authority inspections
Minimum requirements	Bachelor's degree in science or health French and English Three (3) to five (5) years of experience combined in quality assurance / quality control and pharmaceutical development. At Sandoz Canada, we are committed to equitable access to employment opportunities and workplace diversity. Only candidates selected for an interview will be contacted.                           Appy