QA/QC Deviations Investigator Toronto, ON Background:
Pharmaceutical Manufacturing for the public/commercial, perform root cause analysis of non conformities (deviations)§ Investigation process includes the following:
§ Work closely with manufacturing, facilities, engineering, and Quality Control/Assurance departments as part of the investigation process.
§ Interview SME, perform GEMBA walks, review relevant standard operating procedures, job aid, work instructions to understand the nature of the deviation.
§ Gather information from all necessary internal sources such as cleaning logs, equipment work orders, Certificate of Analysis, calibration records, batch records, training records, etc and external sources such as raw material C of A, equipment handbooks, etc.
§ Identify the root cause of the deviation using different root cause analysis techniques such as Fish bone, 5 Whys, FMEA, etc.
§ Review historical trends and impact analysis on all manufactured product, as well as risk to future operations.
§ Collaborate with SME on identification of the Corrective and Preventive actions.
§ Work independently and comply with Deviation, Change Control management and Corrective and preventive actions procedures.
§ Ensures deviation deadlines are monitored closely and are met .
• Candidate requirements § BS/BASc Degree in science/engineering field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.
§ Experience utilizing root causes analysis tools and identifying corrective and preventative actions is required.
§ Detailed oriented with strong analytical and problem-solving skills.
§ Excellent verbal and written communication skills with advanced writing skills.
§ Good deductive and inductive critical thinking skills with attention to detail and ability to manage multiple deviations with shifting priorities
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