Position Title Aseptic Specialist (Evening Shift)

Job ID	131304BR
Division	Sandoz
Business Unit	Sandoz - Technical Operations
Country	Canada
Work Location	Montreal South Shore – Boucherville
Company/Legal Entity	Sandoz Canada
Functional Area	Production
Job Type	Full Time
Employment Type	Regular
Job Description	Choosing Sandoz, a healthy decision. Located in Boucherville, Québec and counting over 950 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 an Aseptic Specialist (Evening Shift). Reporting to the Aseptic Compliance Supervisor, the Aseptic Specialist is responsible for ensuring the compliance of aseptic areas on a daily basis. He or she also upholds procedures related to aseptic processing techniques, the aseptic fill simulation (Media Fill Test) and gowning qualification programs, and the training of staff. Summary of tasks: He/she carries out checks/assessments of aseptic production areas on a daily basis; Ensures that staff working in aseptic areas comply with best aseptic practices; Prepares and delivers annual training in aseptic practices, including monthly communication capsules for staff working in aseptic areas; Makes recommendations for improvements in aseptic areas and reports cases of non-compliance with best aseptic practices; may grant or revoke certification for compliance or non-compliance with best aseptic practices. He/she provides the first contact upon the discovery of a deviation from an operational process. He/she supports the production department by ensuring a good understanding of the situation, thus allowing for nimble decision-making with regard to immediate corrective measures and documenting requirements so as to ensure operational compliance. Working with the production department, he/she ensures that procedures and quality systems are applied and complied with. He/she must be familiar with and monitor quality indicators on an operational level in order to achieve release time frames. He/she takes part in reviewing/approving SOPs and change notices generated by microbiology and manufacturing operations that could potentially impact the quality of packaged or manufactured products. He/she drafts technical assessments to justify changes to aseptic procedures in effect. He/she supports other departments in certain projects or initiatives affecting aseptic operations (engineering, shutdown, remediation, etc.) and ensures compliance with regulations.
Minimum requirements	Bachelor's degree in microbiology French and English One (1) to three (3) years experience with knowledge of aseptic operations – the incumbent must be familiar with the FDA’s “Sterile Drug Product Produced by Aseptic Processing” guideline and GMP At Sandoz Canada, we are committed to equitable access to employment opportunities and workplace diversity. Only candidates selected for an interview will be contacted.