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Quality Supervisor

3 weeks ago

SaintLaurent, Canada Medisca Pharmaceutique Inc Full time

The **Quality Supervisor** is responsible for supervising the operations of all quality related aspects within the Quality department throughout daily operations, at MEDISCA’s Dobrin facility. This individual will have a team of direct reports. This role reports directly to the Quality Manager.
**THE OPPORTUNITY**:
**Quality**
- **Material Inspection and Release**:

- Oversee the inspection and release process of incoming material.
- Support the technical inquiries with external third party testing laboratories.
- Oversee the production activities related to re-packaging processes.
- **Review and Approval of Standard Operating Procedures**:

- Collaboration on MEDISCA’s Standard Operating Procedures.
- Ensure Standard Operating Procedures are aligned with external regulations that govern the compounding industry.
- **Quality Events**.
- Support the quality customer complaints, deviations and non-conformances processes.
- Lead a comprehensive and effective investigation of deviations and non-conformances.
- Document, review and approve quality impact assessments.
- Identify scientifically sound root causes and implement robust CAPAs.
- **Quality Assurance Documentation**:

- Oversee the documentation process related to Specifications, Certificate of analysis, SDS, Labels, Statements and Change notices.
- Collaborate during the documentation review and approvals.
- Oversee the stability program management process.
- **Environmental Monitoring and Equipment**:

- Oversee the environmental monitoring program in the facility.
- Oversee the equipment calibration and maintenance program.
- **Returns**:

- Oversee the handling of returned material.
- **Change Control Process**:

- Support the change control process related to the Quality department.
- Collaborate in the quality assessment CRs and provide comprehensive feedback.
- **Quality Metrics**:

- Generate the KPIs related to the performance of the team.
- Collaborate during the monthly quality management meeting review.
- Collaborate to the continuous improvement in the department.

**People Leadership**
- Ensure team members understand and follow cGMPs and MEDISCA policies and procedures.
- Lead members of your team; guide them to perform at their best. Set and manage clear targets and KPIs and monitor progress.
- Foster a high driven culture within your team by empowering them to bring their best selves to work.

**TRAVEL**: Minimal travel, one (1) to three (3) times per year to attend conferences.
**SKILLS, ABILITIES AND KNOWLEDGE**:

- Bachelor of Science
- Minimum three (3) to five (5) years experience in Quality and/or Regulatory Affairs
- Knowledge of cGMPs, 21 CFR Part 211, GUI-0104, GUI-0069; ICH Guidelines; ISO 9001; ISO 13485.
- Previous experience in supervision and/or management, with a strong leadership presence.
- Excellent communication skills required; fluent English & French (oral & written). This position interfaces with facilities in the Unites States and Australia.
- Analytical, with the ability to make data & people driven decisions.
- Great time & project management skills.
- Very good command of Microsoft Office (Word, Excel, Outlook)
- Experience with MasterControl is a strong asset

*
Experience*
Preferred
- 3 - 5 years: Quality and/or Regulatory Affairs

**Education**
Preferred
- Bachelor's degree or better in Science