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Quality Compliance Specialist
2 weeks ago
**Basic Function**:
Support through effective execution the following critical quality systems:
- Audits
- Vendor Qualification
- Annual Product Review
- Regulatory Affairs
- Quality Agreements
- CAPA
- Change Management
- Risk Management
This position will work closely with all members of the Quality Services department and may be called upon to act as initiator and where applicable act as an independent reviewer/approver for any of the above systems.
Ensure the processes are executed efficiently and in accordance with HPFB and FDA Good Manufacturing Practices Guidelines and customer requirements.
**Responsibilities**:
- Suggest necessary improvements to the quality systems, reducing their complexity to an appropriate level and instilling the organizational energy required to deliver them. Quality systems need to be simpler, quicker and less costly to administer while being fully current and compliant, to achieve the outcomes and results required by all stakeholders.
- Maintain vendor/supplier qualification program by gathering information to support approval and certification of vendors.
- Liaise with customers, as required to provide responses related to questions received from consumers.
- Where required, lead internal and external vendor audits (vendor qualification), prepare audit reports and complete audit follow up.
- Initiate change management processes applicable to changes in quality systems and facilitate closure through effective execution of deliverables and full implementation of proposed changes. This position may also act as an independent reviewer/approver for another change owner.
- Initiate document control processes applicable to changes to documents associated with quality systems.
- Initiate and/or own CAPA processes applicable to quality systems.
- Assess CAPA actions to determine if they were effective
- Participate in customer and/or regulatory audits in varying capacities as required.
- Where required, facilitate effective risk management processes and effectively document risk based decisions.
- Provide support for administration of Quality Metrics Review (QMR) data for management review.
- Keep current on FDA and Health Canada guidelines regarding Quality and Compliance.
- Prepare/review Annual Product Reviews on-time and per customer and regulatory requirements.
- Provide support for Regulatory Affairs.
- Other duties, as assigned.
**Educational/Experience Requirements**:
- Minimum 5 years of experience in a GMP regulated environment in a quality assurance or quality compliance role
- University Degree in a related science
- Demonstrated problem solving skills
**Job Types**: Full-time, Permanent
**Salary**: From $65,000.00 per year
**Benefits**:
- Company pension
- Dental care
- Employee assistance program
- Extended health care
- Life insurance
- Profit sharing
Schedule:
- 12 hour shift
- 8 hour shift
- Day shift
- Monday to Friday
- Night shift
- Weekend availability
Ability to commute/relocate:
- Brockville, ON: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (preferred)
**Experience**:
- GMP or related: 5 years (required)
