Job Description

Company DescriptionWe are SGS - the world\'s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 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;
• 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\xef\x82\xb7 Candidates must be proficient in using various type of computer software (Word, Excel, PowerPoint, Outlook etc.) and be able to demonstrate good keyboarding skills.

Additional InformationSGS 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#SGSSJ

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