Quality Assurance Manager

2 months ago

North York, Canada Canadian Custom Packaging & The Color Group Full time

Position Title: Quality Assurance Manager
Reports to: VP of Operations
Type of position: Full time - On-Site - Permanent

Position Overview:
This position is responsible for the overall day-to-day management of all QA activities required to ensure that CCP’s products and services are fit for purpose and meet all external and internal requirements. Scope includes Quality Control and Good Manufacturing Practices (GMP) that covers raw material sampling, specifications, testing, documentation, microbiology and QA release processes associated with both raw materials, packaging and finished goods.

Key Responsibilities:

- Coordinate all activities required to meet quality management system standards
- Ensure tests and procedures are properly understood, carried out and evaluated and that product modifications/changes are investigated and documented (e.g., deviations, out-of-specification, change control, product rework)
- Supervise a team of chemists and microbiologists in carrying out all testing and QA activities
- Ensure products meet all required specifications prior to the release of finished goods
- Collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS
- Participate in regular management reviews; review and discuss operational performance measurements and propose measures to achieve continual improvement.
- Liaise with all internal managers and staff throughout the organization to ensure that the QA system is functioning properly
- Where appropriate, advise on changes and their implementation
- Determine SOP requirements and provide QA review of SOP’s
- Identify relevant quality-related training needs and deliver training
- Manage customer complaint process
- Ensure complaints are examined and investigated thoroughly to determine root causes, initiate corrective/preventive measures to prevent recurrence of the problem.
- Communicate with the appropriate Regulatory body for any reportable situations including, product recalls, medical device advisory notices and ADR’s, (adverse reactions to marketed health products).
- Conduct annual reviews (APQR, ADR) consistent with applicable statutory and regulatory requirements; produce / distribute summary reports and notify Ministry of significant change as per regulatory guidance.
- Assist with and participate in internal and external audits and manage GMP self-inspection activities
- Responsible for Hazardous Waste Information Network (HWIN), assign code for chemicals for waste disposal
- Review and provide guidance on accelerated and long term product stability and compatibility

Skills and Qualifications:

- Practical, hands-on experience in all aspects of QA, including proficiency in microbiology.
- Proficient in Microsoft office, including: outlook, word, excel, power point, TEAMS, etc.
- Excellent organizational, time management, written and verbal communication skills.
- Demonstrated ability to work well under pressure, while managing conflicting priorities and tight deadlines.
- Ability to work professionally and collaboratively with all internal departments and external customers.
- Self-starter who is analytically minded, an adept problem solver and able to work independently and efficiently.
- Good theoretical and practical knowledge of quality management systems such as ISO 13485:2016 MDSAP, ISO 22716:2007, principles of GMP, philosophies such as TQM and methodologies such as Continuous Improvement.
- 5+ years in manufacturing environment as asset.
- 5+ years of managing a QA/QC team required.
Education Requirements:
Must meet Health Canada’s education and experience criteria.
Bachelor of Science Degree, related to the work.

Schedule:

- 8 hour shift

Supplemental pay types:

- Overtime pay

Ability to commute/relocate:

- North York, ON: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- quality assurance: 1 year (preferred)

Work Location: One location

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