Quality Management System Investigator

7 days ago


Mississauga, Ontario, Canada SGS Full time
Job Description 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; Follow Training Procedure (SOP) for training and training records; Participates or leads CAPA /Complaint process. Investigates CAPAs of QA. Performs QA Review/ approval of methods. May review validation protocols or reports of methods or equipment. Perform Internal audits; Follows up on corrective action Perform corrective action for internal audits and external audits Prepare responses to external audits reports In case of a deviation from SOP initiates a deviation form and investigates, justifies and performs root cause analysis and corrective action.

Qualifications

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 Thorough knowledge of scientific principles pertaining to records under investigation. Works well under pressure and tight deadlines Excellent written and verbal communications Candidates must be proficient in using various type of computer software (Word, Excel, PowerPoint, Outlook etc.) and be able to demonstrate good keyboarding skills.


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