Qc Investigator
5 days ago
Company Description
WE ARE SGS - THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY. WE ARE RECOGNIZED AS THE GLOBAL BENCHMARK FOR QUALITY AND INTEGRITY. OUR 89,000 EMPLOYEES OPERATE A NETWORK OF 2,600 OFFICES AND LABORATORIES, WORKING TOGETHER TO ENABLE A BETTER, SAFER AND MORE INTERCONNECTED WORLD.
**Job Description**:
- 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.
- 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
**Qualifications**:
- 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
Additional Information
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