Quality System Specialist

4 months ago


PointeClaire, Canada MedXL Full time

**_JOB SUMMARY :_**

Reporting to the Quality Operations Director, the specialist is responsible for providing quality assurance support to the various departments of the factory.

**_MAIN RESPONSIBILITIES :_**
- Coordinate special projects for the department (eQMS, ISO 13485, continuous improvement, etc.).
- Ensure compliance of manufacturing, SM and STM procedures.
- Support complaint investigations.
- Support the Change Control and Deviation program.
- Monitor the implementation of Change Controls and ensure their effectiveness.
- Support data collection and writing of APQRs and management reviews.
- Support the internal audit program.
- Provide support to the supplier management program.
- Guarantee GMPs throughout the factory processes.
- Establish and maintain quality standards aligned with applicable international cGMP regulations and guidelines.
- Any related functions.

**_ORGANIZATIONAL RELATIONSHIPS :_**
- Purchasing / Supply Chain
- Production
- Quality Group

**_JOB REQUIREMENTS :_**

**_Education _**_:_**
- BAC in science or any related discipline.

**_Experience_**_ _**_:_**.
- Minimum 5 years of experience in the pharmaceutical industry.

**_SKILLS/QUALIFICATIONS_**_:_**
- Bilingual
- Knowledge of MS Office (Word, Excel)
- Demonstrated interpersonal skills
- Collaborate successfully with various departments
- Experience in microbiology would be an asset
- Must be available to support a plant that operates 24 hours/7 days a week.

**_WORKING ENVIRONMENT_**_ _**_:_**
- Office, production (occasionally)



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