- 6490 Vipond Dr, Mississauga, ON L5T 1W8, Canada
Make an impact with SGS! With more than 97,000 employees and 2,600 offices and laboratories across the world, SGS is a silent force working hard behind the scenes to deliver quality and integrity to businesses across nine industries. As the world’s leader in providing inspection, verification, testing and certification services, Forbes ranked the SGS Group as one of the world’s top multinationals and one of the world’s most innovative companies. The Dow Jones Sustainability Index has also recognized the SGS Group for its sustainability processes. In Canada, SGS employs over 2,000 team members across 70 locations.
- Leads OOS's, Deviations, and CAPA’s technically and administratively
- Conducts OOS investigations on a daily basis where SOP and regulatory guidelines are followed.
- Writes the OOS with feedback from the SME’s/Managers/QA and reviews all associated raw data and records; Leads the determination of sequence of events and leads root cause analysis.
- Develops hypothesis testing plans in collaboration with Quality Assurance, subject matter experts, and the client. Provides systematic and detailed OOS reports.
- Completes investigations on-time as per investigation SOP
- Participates in CAPA investigations if requested by CAPA owner or QA. Reviews CAPAs according to CAPA SOP
- Performs validation, or other failure investigations
- Initiates deviations. Leads and investigates deviations, justifies and performs root cause analysis and corrective action according to internal SOP and regulations
- Contributes to on-time CAPA process according to SGS SOP. May write stability protocols as per client requests and communicates effectively with clients if required
- May write/review QC methods, review validation protocols or reports of methods or equipment
- Education: Bachelor of Science (M.Sc. or higher preferred) in Biology, biochemistry or related fields.
- Experience: over 5 years’ pharmaceutical testing experience with exposure to root cause investigations and quality management systems.
- Knowledge of OOS Investigation regulatory process
- Knowledge and experience of using root cause analysis tools
- Thorough knowledge of scientific principles pertaining to records under investigations
- Works well under pressure
- Ability to work fast and make timely decisions where required (e.g. hypothesis testing, repeat test approvals etc.)
- Excellent written and verbal communication
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.