QMS Investigator

As a QMS Investigator, you’ll join an open and sharing community with highly skilled colleagues, and you can come as you are and be at your best at SGS Company.

For more understanding concerning the QMS Investigator, this post has the requirements, responsibilities, and other pieces of information.

Job Details

• Name: QMS Investigator
• Location: 6490 Vipond Dr, Mississauga, ON L5T 1W8, Canada
• Company name: SGS Company
• Salary: CA$92,509 per year or CA$30.96 per hour
• Terms of employment: Full-Time
• Job Type: Regular.

Company Description

They are SGS – the worlds leading testing, inspection, and certification company.

SGS Canada is an equal opportunity employer, and they are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process.

The accommodations are available on request for qualified candidates during each stage of the recruitment process.

They are the global benchmark for quality and integrity; their 89,000 employees operate a network OF 2,600 offices and laboratories, working together to enable a better, safer, and more interconnected world.

1. Perform root cause analysis for Out of Specifications Investigations OOS), Deviations, Complaints, and Corrective action (CAPA) so that SGS will not get a Health Canada observation or a US FDA 483 during regulatory audits.
2. Follow the Training Procedure (SOP) for training and training records
3. Guides OOS results in investigations daily where SOP and regulatory guidelines are followed;
4. Guides operations on how to write the OOS; reviews and approves OOS investigations
5. Provides support in OOS investigations to the sequence events and root cause analysis or other techniques.
6. Approves OOS hypothesis testing, repeat test, and final OOS Investigation according to internal SOP.
7. Investigates CAPAs of QA. Participates in CAPA; investigations if requested by CAPA owner or QA supervisory. Participates in or leads CAPA /Complaints process.
8. Reviews and approves CAPAs according to CAPA SOP.
9. Initiates deviations, investigate, or approves deviations according to internal SOP and regulations.
10. Initiates or leads improvements to improve Key Performance Indicators KPIs for the correctness of C of A. Plots the C of A incorrect %/sample or total samples per month for root cause analysis.
11. Reviews stability protocols per client requests and communicates effectively with clients if required.

Qualifications

1. Minimum education BSc. In Biology, chemistry, or related fields.
2. Experience: 5 years of pharmaceutical testing experience.
3. Five years of experience in root cause investigations.
4. Skilled in a pharmaceutical testing individual who has experience/capability to perform thorough investigations into root cause analysis
5. Knowledge of the OOS Investigation regulatory process
6. Knowledge and experience in using root cause analysis tools
7. Works well under pressure and tight deadlines.
8. Ability to work fast and make timely decisions where required (e.g., hypothesis testing, repeat test approvals).

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