Job Summary:

To organize, execute and manage all aspects of the quality assurance operations. The QA Supervisor is responsible for all aspects of GMP compliance.

Key Responsibilities:

- Design, maintain and manage Quality programs inclusive of Standard Operating Procedures
- Manage quality documentation inclusive of all laboratory logbooks and worksheets
- Manage and approve all required change control requests and deviation reports
- Review and approve validation protocols
- Review and have executed all analytical methods; method validations and method technology transfer studies
- Review analytical raw data and publish Certificates of Analysis of standards
- Approve all annual trending reviews
- Review and approve certificates of analysis
- Manage QA activities to insure compliance with current GMP requirements
- Lead process for the execution, investigation and documentation of all laboratory OOS occurrences
- Host/Support GMP audits from clients and regulatory agencies such as Health Canada
- Manage the stability protocols associated with chamber qualification, calibration and sample removal dates
- Manage internal/customer/regulatory audits; and identify, evaluate and implement effective corrective actions
- Interface with all vendors to insure appropriate calibration and maintenance is performed
- Review and approve internal and external calibration reports
- Provide oversight of quality programs and make quality-related decisions & troubleshoot all analytical issues
- Develop and manage GMP training programs
- Manage overall CAPA program to include investigation, root cause analysis, corrective and preventative actions and documentation
- Identify and implement continuous improvement initiatives
- Maintain all relevant records for appropriate retention times
- Conduct review of key quality indicating parameters and submit reports to management

Minimum Requirements:

- Chemistry degree or equivalent
- Three to Five years Canadian Experience
- Knowledge of GMP, chemical and microbiological concepts
- Ability to organize, communicate, teach, and work with others in an effective manner
- Working knowledge of basic computer systems and software applications
- Considerable working knowledge of the methods, materials, and techniques used in laboratory work
- Ability to supervise and schedule the work of others

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