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Quality System Specialist
7 days ago
Job summary
Reporting to the Manager, Quality Assurance, the specialist is responsible for providing quality assurance support to the various departments of the plant.
Main responsibilities:
- Support the Change Control program.
- Monitor the implementation of Change Controls and ensure their effectiveness.
- Support data collection and drafting of APQPs and PMS.
- Support the internal audit program.
- Support the supplier management program.
- Support the document management program, including related administrative tasks and archiving.
- Support the administration of eGMSs.
- Provide support for manufacturing investigations (complaints, nonconformities, CAPA, etc.), as needed.
- Coordinate special projects for the department (eQMS, ISO 13485, continuous improvement, etc.)
- Ensure GMP throughout plant processes.
- Depending on the qualifications, may be required to perform the tasks of the biosafety officer on the site (containment level 2 laboratory).
- Establish and maintain quality standards aligned with applicable international cGMP regulations and guidelines and ISO standards.
- The list of tasks and responsibilities mentioned above is not restrictive. In the performance of your duties, the Quality Assurance Specialist performs any task related to your job for the proper functioning of the organization.
- DEPENDING ON QUALIFICATIONS, may be required to perform the tasks of the biosafety officer on site (containment level 2 laboratory).
Organizational relationships:
Collaborates with the operations, logistics, warehouse, maintenance, validation and laboratory departments.
Job requirements
_EDUCATION__:
_**_ BAC in science or any related discipline._
_EXPERIENCE__ _
_:
_.
- A minimum of 5 years of experience in a pharmaceutical industry._
_:_
- _Knowledge of Microsoft Office (Word, Access, Excel)._
- _Very good _knowledge_ of Good Manufacturing Practices (GMP)._
- _Demonstrated interpersonal skills._
- _Work independently and demonstrate excellent team spirit._
- _Collaborate successfully with various departments._
- _Experience in microbiology would be an asset._
- _Must be available to support a plant that operates 24/7._
- _
_Other:_
- _Spoken/written lagunages :_
- Excellent verbal and written communication is required, both in English and French._
Deadline for CV's _:
March 14, 2023_
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