Quality Assurance Manager

3 weeks ago

Brampton, Canada Sigan Industries Group Full time

**POSITION TITLE: Quality Assurance Manager**

**REPORTS TO: Director QA/QC**

**LAST DATE REVISED**: April 2024

**INCUMBENT**:
***

The Quality Assurance Manager will be responsible for implementing quality processes and procedures, building and maintaining a robust quality management system, working with R&D Quality Control and Production teams ensuring that products meet all standards of quality. The QA manager will ensure regulatory compliance and work on continue process improvements.

**KEY DUTIES AND RESPONSIBILITIES**
- Oversee the maintenance and improvement of the company's quality management system to comply with applicable regulatory standards and industry best practices.
- Lead inspections and audits with health authorities, including FDA, Health Canada, ISO, clients, etc
- Coordinates quality trainings. Responsible for ensuring that functional areas of responsibility have adequate training programs for adhering to all safety requirements and regulatory compliance
- Manage and monitor Corrective and Preventive Action ( CAPA)
- Implement continuous improvement initiatives to enhance quality processes, reduce defects, and optimize overall product quality.
- Establish and maintain quality agreements that outline clear quality expectations, standards, and responsibilities.
- Regularly review and update quality agreements to reflect changes in regulations, processes, or product specifications.
- Ensuring that products meet quality standards and specifications
- Establishing and enforcing quality procedures, standards, and specifications
- Stay current with changes to current Good Manufacturing Practices, FDA, Health Canada, EU, MOCRA requirements
- Overview daily operations of Quality Assurance team
- Participate in the set-up and operation of validation processes, pilot scale requirements; completion of small production runs and scale-up/ optimization of manufacturing process
- Develop and analyze statistical data and product specifications to determine standards and to establish quality expectancy of finished products
- Verify and maintain quality assurance records, statistical reviews and relevant documentation
- Review and provide directions on product stability
- Analyze problems related to Quality i.e. Delays, OOS, Deviation, rejects, and inadequate controls, etc., determine the root cause and establish measures to correct the problem
- Liaise with other teams and staff throughout the organization to assure consistent quality
- Ensure all legal and regulatory standards are met

**REQUIRED EDUCATION AND EXPERIENCE**
- Bachelor’s degree in chemistry or similar
- 7 years or more of experience in the pharmaceutical and/or cosmetic industry including experience in a Quality or Compliance position.
- Lean Sigma or other Quality Sciences is preferred.

**REQUIRED KNOWLEDGE AND SKILLS**
- In depth understanding of quality assurance processes and relevant legal standards
- Knowledge of cGMP requirements, quality systems, and pharmaceutical/ cosmetic manufacturing
- Collaborative leadership approach
- Excellent communication and interpersonal skills
- Strong attention to detail and a result focused approach
- Ability to work within strict deadlines and a highly compliance driven environment
- Prior experience in pharmaceutical and personal care industry is required

**Benefits**:

- Dental care
- Extended health care
- Life insurance
- On-site parking

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (required)

**Experience**:

- quality assurance: 5 years (preferred)

Work Location: In person

Application deadline: 2024-06-01

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