25 Sep
|
Cliantha Research
|
Mississauga
25 Sep
Cliantha Research
Mississauga
General Responsibilities
- Handles tasks under direction and guidance
- Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency and completeness
- Work with QC manager and QC Specialists to ensure study specific QC plans are followed during clinical trials, ensuring QC processes are in alignment with Inflamax SOPs and study protocols
- Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
- Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required under the guidance of QC manager/QC Specialists
- As required, follow-up on all QC findings, until a satisfactory resolution has been determined
- Assure documentation review meets or exceeds designated timeline parameters
- Maintain a working knowledge of relevant US, Canadian and European GxP regulations as well as ICH regulations
- Ensuring training file and SOP reading is maintained and up to date
- Ensure compliance with appropriate Inflamax SOP’s, GCP and ICH guidelines
- Participate in training sessions
- Participate in training of staff as experience and qualifications permit
- Work in a protected manner that does not endanger yourself or co-workers
- Execute other duties as may be required by the QC Manager and other members of the management team as training and experience allow
📌 Quality Control Specialist (Mississauga)
🏢 Cliantha Research
📍 Mississauga