Quality Assurance Investigator
1 month ago
SGS is seeking a highly skilled Quality Assurance Investigator to join our team. As a Quality Assurance Investigator, you will be responsible for conducting root cause analyses for Out of Specifications Investigations (OOS), Deviations, Complaints, and Corrective Action (CAPA) to ensure SGS meets regulatory requirements.
Key Responsibilities- Conduct thorough investigations into root cause analysis to identify and correct deviations from standard operating procedures (SOPs).
- Participate in or lead CAPA/Complaint processes, investigating QA-related CAPAs.
- Review and approve quality methods, ensuring compliance with regulatory requirements.
- May review validation protocols or reports for methods or equipment.
- Perform internal audits, following up on corrective actions.
- Prepare responses to external audit reports.
- In case of a deviation from SOP, initiate a deviation form, investigate, justify, and perform root cause analysis and corrective action.
- Minimum education: BSc. in Biology, Chemistry, or related fields.
- Experience: 5 years in pharmaceutical testing and 5 years in root cause investigations.
- Skilled in pharmaceutical testing, with experience in 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.
- Ability to work well under pressure and tight deadlines.
- Excellent written and verbal communication skills.
- Proficient in using various computer software (Word, Excel, PowerPoint, Outlook, etc.) and good keyboarding skills.
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