Quality Assurance Documentation Assistant
QUALITY ASSURANCE DOCUMENTATION ASSISTANT JOB DESCRIPTION:
The Quality Assurance Documentation Assistant is responsible for database management, archiving, filing and ensuring all documentation is maintained and up to date. This role ensures and monitors adherence to all facility SOPs relating to current Health Canada regulations, GMPs, and other applicable regulations, and aids in the auditing process. They report to the Quality Assurance Manager.
- Assists in quality assurance activities and ensure compliance with Health Canada’s regulations and GMP requirements pertaining to production, processing, packaging, labelling, shipping.
- Ensure compliance with regulations by assisting with internal auditing and quality systems by providing support related to audits in production, facilities and maintenance for inventory, GMP and process quality compliance.
- Maintaining accurate record keeping.
- Liaise closely with colleagues and provides required QC/QA training for all areas of the production facility to ensure efficient resolution of quality-related issues – maintain SOP process – coordinate updated training when SOPS are revised.
- Follow procedures efficiently and consistently in and production environment.
- Provides support to ensure compliance of Change Control System, Complaints System, Validation System and Deviation Investigation Reports (DIR), including Root Cause Analysis (RCA), Corrective and Preventative Action (CAPA).
- Supports the creation of annual Product Quality Review.
- Assists quality assurance requirements for production R&D projects.
- Assist with operational activities as required.
- Science or administration educational background.
- 1-3 administrative experience.
- Able to successfully obtain clear criminal record check.
- Previous Health Canada Security clearance and work experience with a Canadian license holder is an asset.
- Knowledge of GDP principles.
- Strong knowledge of MS Word, Excel and Outlook.
- Excellent attention to detail.
- Excellent time management and prioritization skills.
- Oriented towards quality work and service.
- Capable of multitasking with minimal supervision.
- Excellent English communication skills both written and verbal.
Please send your resume and cover letter to email@example.com
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