Aseptic Specialist

Job description

Job Description

Located in Boucherville, the Canadian division of Sandoz houses one of the most important sterile pharmaceutical manufacturing sites in the country. Our vision: to become the main provider of high quality, affordable medicines and help secure long-term access to healthcare for people around the world. If you are results oriented and recognized for your leadership, expertise, commitment to quality and customers, come join our team !

We are currently looking for an Aseptic Specialist:

Reporting to the QA Shop Floor 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.

Desired profile

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.