Quality Control Investigator- Chemistry

3 days ago

Mississauga, Canada SGS Full time

Company Description

Make an impact with SGS With more than 94,000 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.

**Job Description**:

- Leads OOS’s, Deviations, and CAPA’s technically and administratively.
- Completes investigations on-time as per investigation SOP.
- Participates or champions CAPA /Complaint process. Investigates CAPAs on behalf of QC. Participates in CAPA investigations if requested by CAPA owner or QA. Reviews CAPAs according to CAPA SOP.
- Performs validation, or other failure investigations.
- Follows up on corrective action
- Perform corrective action for internal audits and external audits
- May support preparation of responses to external audit reports by providing responses on behalf of operations.
- Ensure that client requests and complaints are dealt with effectively.
- 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.
- May write/review validation protocol or reports of methods or equipment.
- May perform review of calibration records or testing records.
- May perform impact assessments.
- Informs applicable personnel in time if work cannot be satisfactorily completed on scheduled time, so other resources can be utilized to meet the deadline.
- Attend training sessions and ensure that training binder is current.
- Keep the working areas clean and organized according to laboratory procedures.
- Training departmental staff on documentation, regulatory issues and corrective action.
- Perform other assigned laboratory / quality control duties as requested by supervisor.
- Provides leadership in compliance.
- Prepares weekly reports of progress on assignments.

**Qualifications**:

- Minimum education B.Sc. (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.
- 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.
- Works well under pressure and tight deadlines.
- Ability to work fast and make timely decisions where required (e.g. hypothesis testing, repeat test approvals etc.)
- Proven time management skills. Managing multiple assignments.
- Highly organized
- Deliver results in a timely manner
- Proven track of working well with others.
- Excellent written and verbal communications
- As per Orientation and Training SOP all employees must maintain appropriate attitude, constant vigilance and attention to detail in the execution of all their duties.
- All training is kept up to date and relevant in advance of conducting any work where training is required
- Incumbents are responsible for their own training records according to training SOP.

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