Quality Management System Investigator
2 weeks ago
**Company Description**:
- We 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 _**_2,6_**_0_**_0 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.
**Additional Information**
SGSSJ
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