General Job Description:
The Quality Manager will aid in implementing and maintaining quality systems and procedures. Utilizing Good Manufacturing Practices (GMP) and having superior knowledge of compliance requirements set by Health Canada and EudraLex, the Quality Manager will ensure quality, efficacy, and safety of product and systems. The Quality Manager will always follow and advise on AGMEDICA Standard Operating Procedures (SOP) and the Cannabis Act and its regulations. Working under the direction of the Director of Quality and Compliance, perform all tasks, including, but not limited to, risk management, participation in inspections and audits, quality incident report writing, and work as a cooperative member of the quality assurance team. team.
Major Duties:
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Know and follow the Cannabis Act and its regulations, advise on updates when necessary; when necessary;
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Develop, implement and maintain various quality programs and systems, including Hazard Analysis and Critical Control Points (HACCP), Good Manufacturing Practices (GMP), Good Agricultural and Collection Practices (GACP), Good Production Practices (GPP);
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Carry out production, process, and analytical testing activities as per approved standard operating procedures to provide top quality cannabis products;
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Developing, implementing and reviewing strategies for standard operating procedures, references, and records using software systems; research, coordinate and implement special projects or requirements;
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Perform Quality compliance audits (internal and external) and advise on system improvements; including audits of cannabis plants, processed cannabis, waste inventory, and vendor evaluation;
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Work closely on preparation of audits and corrective action plans with Quality Assurance Person and Alternate Quality Assurance Person;
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Quality Management System maintenance and compliance, including management of complaints, non-conformances, deviations, out of specifications, corrective and preventative actions, supplier correction actions and other QMS functions; ensuring completion of review, documentation, investigation, implementation and closures;
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Investigation and review of any client concerns (adverse effects/adverse events, retrievals, or recalls), determine root cause, defining and implementing the corrective action, and perform reporting requirements;
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Advise on system improvements and process development strategies;
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Coordinate QA/QC team members for daily quality assurance and quality control tasks;
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Coordinate quality team members to ensure the dissemination and prioritization of QA and QC tasks are aligned with operational expectations;
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Coordinate quality team members to provide annual, quarterly, monthly, and as requested reports for use in APQR and MRT;
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Guiding and training of personnel, ensure checks and balances for quality, efficacy and safety are at all times followed;
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Mentor and ensure that on-site QA team members are able to perform Quality Supervisor duties in case of absence;
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Support Stability Program, including protocol and report writing and review of reports as required;
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Support qualification and validation activities including protocol and report writing and review of reports as required;
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Hold security clearance under Health Canada and act as Alternate Quality Assurance Person (AQAP).
Other Duties:
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Employ professional and clear communication practices to maintain a positive and progressive team atmosphere across all departments.
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Document and track information utilizing advanced computer software systems
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Attend and share in employee meetings; participate in performance reviews.
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Work with little supervision and maintain a high level of performance
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Comply with all HR policies including confidentiality and non-disclosure.
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Carry out other duties as assigned by the Director of Quality and Compliance.
Requirements:
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Always adhere to AgMedica Standard Operating Procedures (SOP) to obtain quality, efficacy and safety in all quality assurance protocols and operations;
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Ensure all federal, provincial, and municipal regulations for compliance are implemented and followed during all production, processing, packaging, and maintenance operations;
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Familiar with and follow the Cannabis Act and its regulations; follow GMP standards.
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Personal Protective Equipment must be worn; gowning and area procedures must be followed as per SOP Proper Protective Equipment and SOP Employee Health Hygiene and Dress Code Policy
Qualifications:
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Post Secondary Education in Chemistry, Biology, Pharmacy or a related field.
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5+ years of experience in a Quality Assurance role or relevant field, preference given to individuals with GMP and pharmaceutical manufacturing experience
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Experience in and knowledge of Good Manufacturing Practices (GMP).
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Previous work experience with a Licensed Producer (LP) is considered an asset.
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Health Canada security clearance as asset.
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Strong IT knowledge and skills, including superior use of Microsoft Office applications (Outlook, Excel, Word).
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Experience in validation and qualification reporting is considered an asset.
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Demonstrate necessary comprehension of the English language
Physical Demands:
These physical demands are characteristic of the physical requirements necessary for an employee to successfully and safely perform the necessary duties of the job.
While performing the responsibilities of the job, the employee is required to:
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On occasion, lift weight up to 25kg push and pull carts.
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Use hands and fingers, use of manual dexterity is required.
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May be required to stand for long periods of time, balance, walk, reach with arms and hands, bend or twist, and to stoop, kneel, crouch/squat.
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Vision abilities required for this job includes acute vision.
Working Conditions:
While carrying out the responsibilities of the job, the following work environment characteristics are typical of the setting the employee will encounter:
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The noise level in the work environment is generally moderate to loud, increases when equipment engaged.
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Personal Protective Equipment needs to be worn as required
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Under intense lighting, with strong odours, and in temperatures between 70-85°F
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This position includes potential exposure to, pollen, molds, mildew, insects, plant debris, as well as chemicals
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Work regular hours, however, may be required to work evenings and on weekends, sometimes at short notice, especially in times of need for AGMEDICA.
This Job Description is intended to express information essential to understanding the scope of the position and is not intended to be a complete list of skills, abilities, duties, responsibilities or working conditions related with the position. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of the job.
AgMedica will provide mandatory and/or specific training to personnel holding positions that require such training or certification in order to be compliant and successful within their roles (i.e. GMP, JHSC, WHMIS, HCAAP, First Aid, Pesticide/Insecticide).
Core Competencies:
Displays creativity and sound judgement in a changing environment, adjusts to competing demands and shifting priorities. Focused and adaptable. Ability to prioritize and balance a variety of projects simultaneously.
Understand how to interpret and effectively employ the AGMEDICA Software System for complete plant tracking, logging harvest yield weights, waste destruction, managing bulk inventory control, and for monitoring processing of product
Good knowledge of Quality Assurance programs and can effectively communicate with diverse teams across AGMEDICA facilities in order to ensure Good Production Practices, Good Manufacturing Practices, and SOP adherence.
