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Company | Royalmount Laboratories • Laboratoires Royalmount |
Address | Greater Montreal Metropolitan Area, Canada |
Employment type | FULL_TIME |
Salary | |
Expires | 2023-06-04 |
Posted at | 1 year ago |
https://www.linkedin.com/jobs/view/3593231159
Biopharmaceutics (GLP/GCP) Activities
- Responsible for performing Quality Assurance (QA) functions that assure the GLP compliance of the Biopharmaceutics facilities, including regulated studies and projects performed at Pharmascience, and reporting the results of these functions, including all findings and recommendations, to management.
- The QA functions include, but are not limited to, independent assessment of study protocols and study plans, drug shipment, Trial Mater Files, TK/PK data review, system validation records, system use, laboratory procedures, equipment records, training records, study data, and reports to determine the level of compliance with applicable Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) regulations, company policies (POL), SOPs, and study protocols.
- Performs in-process audits according to protocols/study plans, GLPs, and departmental SOPs.
- Must assist management in the following three areas covering quality assurance and compliance: study/ project activities, facility/ compliance activities, and client/ regulatory agencies / subcontractor audits. The Senior QA Auditor will be a fully trained individual who can adequately execute within the three areas.
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