WE ARE SGS – THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY. WE ARE RECOGNIZED AS THE GLOBAL BENCHMARK FOR QUALITY AND INTEGRITY. OUR 89,000 EMPLOYEES OPERATE A NETWORK OF 2,600 OFFICES AND LABORATORIES, WORKING TOGETHER TO ENABLE A BETTER, SAFER AND MORE INTERCONNECTED WORLD. 

• Perform root cause analysis for Out of Specifications Investigations OOS), Deviations, Complaints and Corrective action (CAPA) in such a way that SGS will not get Health Canada observation or a US FDA 483 during regulatory audits
• Provides guidance to OOS results investigations on a daily basis where SOP and regulatory guidelines are followed; Provides guidance to operations on how to write the OOS; reviews and approves OOS investigations
• Provides support in OOS investigations to sequence of events and root cause analysis or other technique. Approves OOS hypothesis testing, repeat test and final OOS Investigation according to internal SOP. 
• Participates or leads CAPA /Complaints process. Investigates CAPAs of QA. Participates in CAPA; investigations if requested by CAPA owner or QA supervisory. Reviews, approves CAPAs according to CAPA SOP.
• Initiates deviations, investigates deviations or approves deviations according to internal SOP and regulations.
• Initiates / leads improvements to improve Key Performance Indicators KPIs for correctness of C of A.  Plots the C of A incorrect %/sample /total samples per month for root cause analysis; (or as revised by Management) Uses Pareto chart / risk analysis for scheduling corrective action and improvement to number of correct C of A; Plots KPIs for company objectives
• Reviews stability protocols as per client requests and communicates effectively with clients if required

• Minimum education BSc. In Biology, chemistry or related fields.
• Experience: 5 years pharmaceutical testing experience. 5 years experience in root cause investigations.
• Skilled in pharmaceutical testing individual who has experience / capability to perform thorough investigations into root cause analysis
• Knowledge of OOS Investigation regulatory process
• Knowledge and experience of using root cause analysis tools
• Works well under pressure and tight deadlines.
•  Ability to work fast and make timely decisions where required (e.g. hypothesis testing, repeat test approvals)

SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process.  Accommodations are available on request for qualified candidates during each stage of the recruitment process.

Please note that candidates applying for Canadian job openings should be authorized to work in Canada