Qap (Quality Assurance Person)

Overview

This position reports to the President and is responsible for maintaining compliance requirements as defined by Health Canada. The QAD/QAP will develop and implement GMP/GPP best practices throughout the facility, while managing all QA related activities and documentation. This position is also responsible for the overall management of the Quality Assurance Department and staff.

Key Accountabilities

• Oversee the management of the Complaint program to ensure all critical trends are addressed appropriately and investigations are handled.
• Responsible for assuring the quality of the cannabis before it is made available for sale
• Cleaning and Sanitation: Ensure standards are set and production rooms are kept in optimal conditions. Sanitation program is implemented and effective per the facility’s SOPs.
• Health Canada: Assist with inspections and ensure records are available for expedient review.
• Training, experience and technical knowledge related to the GPP requirements of the Regulations (GMP, GPP, GDP training of new and ongoing staff)
• Ensure Investigation & product reviews are conducted in a compliant matter
• Directly mange the QA Team and staff.
• Coordinate packaging schedule to avoid cross-contamination and product mix-up.
• Responsible for investigating every complaint received in respect of the quality of the cannabis and, if necessary, taking corrective and preventative measures and managing the Recall procedures.
• Review and ensure compliance with the Cannabis Act, QMS, GMP, and approve all SOPs.
• Other duties as operationally required
• Provide guidance to all other departments of with respect to GMP, and Cannabis Act compliance
• Labelling: Ensure labelling operations are consistent with Health Canada requirements.
• Responsible for approval of methods and procedures related to GPP
• Ensure critical items that will prevent initial licensure or result in loss of license are handled.
• Final batch review and release, including review of analytic, and microbial results, and facility conditions, deviations and change controls
• Ensure net weight meets legal requirements.
• Oversee and direct Raw material control system
• Good Documentation Procedures (GDP): Develop/maintain Standard Operating Procedures (SOPs), keep records, collect data, and document incidents.

Experience and Education

· Post-Secondary degree in Sciences or an equivalent amount of experience and education.

· In-depth knowledge in a regulated Quality environment.

· Experience in developing and implementing quality standards and SOPs.

· Experience in working with multiple stakeholders.

· Strong written and oral communications skills.

· Experience managing staff and programs within a regulated industry/environment.

· Proven ability/experience in reading and interpreting legislation and regulations and apply them accordingly.

· Working experience in a highly regulated production environment such as pharmaceuticals, medical devices, food/beverage, alcohol, cosmetics is considered an asset.

· Direct experience within the Cannabis industry considered an asset.

· Active/Prior Health Canada Security Clearance is considered a valuable asset.

Competencies (knowledge, skills, abilities)

· Proficient in MS Office Suite and basic computer systems (Word/Excel/PowerPoint).

· Attention to detail in all areas of security operations.

· Ability to coordinate people and processes, to read and understand technical specifications and to communicate with all levels of staff.

· Excellent organizational and time-management skills.

· A team player with a professional positive attitude.

· Must be able to effectively follow and give directions.

· Ability to effectively communicate verbally and in writing

· Highly effective teamwork skills in conjunction with strong conflict management skills.

· Effective communication skills with individuals at all levels of the organization.

Requirements

The Cannabis Act requires this position to undergo security/background checks, and the individual must be approved by Health Canada as suitable for the Quality Assurance Person (QAP) role.