Quality Assurance Technician

3 weeks ago

Gatineau, Canada Pharmaflorx inc. Full time
The Quality Assurance and Control Manager is responsible for ensuring that production operations comply with regulatory standards and industry best practices. They develop and implement quality strategies aligned with Pharmaflorx’s objectives while maintaining the integrity of the quality system and optimizing processes to ensure maximum efficiency and compliance.

Key Responsibilities:

Quality Strategy and System Implementation

Define and implement a quality strategy in line with Pharmaflorx’s values and objectives, integrating industry trends and regulatory requirements.

Ensure compliance with applicable standards and regulations (Health Canada, GACP, GMP, etc.) by overseeing the implementation, effectiveness, and integrity of the quality system.

Develop and update quality assurance and control procedures to ensure optimal and compliant operations.

QA/QC Team Management and Development

Recruit, train, and oversee quality assurance and control (QA/QC) teams.

Promote a strong quality culture across all levels of the company by training and raising awareness among staff regarding quality requirements and best practices.

Supervise the development and approval of products for both domestic and international markets.

Process Optimization and Quality Improvement

Conduct audits of standard quality assurance procedures to identify opportunities for improvement and optimization.

Develop and oversee continuous improvement plans to maximize efficiency while ensuring regulatory compliance.

Establish and monitor key quality performance indicators and implement corrective actions when deviations occur.

Regulatory Compliance and Validation

Review and approve quality documents required for regulatory submissions to Health Canada and other relevant agencies.

Ensure the validation and qualification of equipment, facilities, and systems according to industry standards (e.g., master validation plan, process and equipment validation protocols).

Assess and manage quality risks by implementing an effective risk management plan.

Required Profile:

Experience:

Minimum of 5 years in quality assurance and control, ideally in the pharmaceutical, biotechnology, or cannabis industry.

Technical Knowledge:

Strong understanding of regulations and standards (Health Canada, GMP, GACP), as well as validation and qualification processes.

Analytical Skills:

Ability to audit, analyze, and optimize quality processes while implementing effective improvements.

Leadership and Team Management:

Proven experience in supervising and training quality teams.

Organization and Attention to Detail:

Strong ability to manage multiple projects simultaneously while ensuring compliance with standards and deadlines.

Communication and Collaboration:

Ability to work cross-functionally with various departments to integrate and reinforce a quality-driven culture within the company.

This role is an excellent opportunity for a quality expert seeking to grow in an innovative and rapidly expanding environment.

The Quality Assurance and Control Manager position requires in-depth expertise in quality management, regulatory compliance, and process optimization. The ideal candidate must possess a combination of technical, analytical, and managerial skills to implement and maintain a high-performing quality system that meets industry requirements.

Technical Skills:

Strong knowledge of applicable standards and regulations (Health Canada, GACP, GMP, ISO, HACCP).

Proven experience in implementing and managing quality systems and regulatory compliance.

Expertise in validation and qualification of equipment, processes, and systems (master validation plan, qualification, and validation protocols).

In-depth knowledge of internal and external audit processes as well as regulatory inspections.

Ability to draft, review, and approve quality documents such as Standard Operating Procedures (SOPs), the quality manual, and validation records.

Management and Leadership Skills:

Experience in managing and training quality assurance and control (QA/QC) teams.

Ability to establish a strong quality culture within the company and train teams on regulatory requirements and best practices.

Leadership skills and the ability to motivate and supervise a multidisciplinary team.

Ability to set quality objectives and monitor performance indicators to drive continuous improvement.

Analytical and Organizational Skills:

Strong attention to detail and rigor to ensure full compliance.

Ability to analyze non-conformities and implement effective corrective and preventive actions.

Excellent organizational skills and ability to manage multiple projects simultaneously in a fast-paced environment.

Strong risk management and problem-solving skills related to quality and compliance.

Communication and Collaboration Skills:

Excellent writing skills for technical documentation and regulatory communications.

Ability to interact with regulatory agencies and prepare submissions and inspection reports.

Strong collaboration skills with other departments (production, R&D, logistics) to ensure seamless integration of quality requirements.

Ability to lead meetings and present compliance or audit results clearly and effectively.

The ideal candidate should be a structured, proactive professional with a strong focus on continuous improvement, capable of ensuring compliance and operational excellence within the company.

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