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Quality Assurance Associate Paris, Ontario – Full Time

Full Time
  • Full Time
  • Paris, ON
  • RElated experience in Pharma or Cannabis industry is critical

Website CCIjobs Career Connections Canada Inc.

The Quality Assurance (QA) Associate reports to the (Senior) Quality Assurance Manager and assures consistent Cannabis product quality before distribution to the customers by developing and enforcing Good Production Practice (GPP) and Good Manufacturing Practice (GMP) systems that comply with Health Canada’s regulations and customer expectations. The Quality Assurance Associate identifies and advises on changes, staff training, deviations, non-conformity issues and associated corrective measures to enable quality standards can be achieved and maintained.

  • Supporting new product development processes by providing quality input on R&D projects and participating in new product launch projects.
    ● Participate in improvement initiatives and special projects as required in other areas of quality and compliance.
    ● Development, review and approval of Standard Operating Procedures (SOPs), Work Instructions, Forms and QA/RA documentation. Assist in establishing a quality management system and ensuring compliance to quality assurance procedures and policies.
    ● Ensuring timely review, follow-up on, closure and approval (as applicable) of various quality documents, such as: operational log books, SOPs, protocols, reports, work orders, worksheets and maintenance task lists.
    ● Providing day-to-day support to all production and quality operations to maintain and to improve compliance to site specific and regulatory requirements.
    ● Generate, evaluate, follow-up and close deviations.
    ● Evaluate, review and approve impact of change requests to product quality, quality management system and ability to maintain compliance.
    ● Initiate corrective and preventive actions (CAPAs) and conduct investigations to address nonconformances, ongoing/trending deviations, Out-of-Specification (OOS) occurrences and as needed. ● Assist in preparation and performance of recall events and mock recall exercises.
    ● Assist in quality complaint investigation and reporting
    ● Manage and maintain QA records in accordance to record retention requirements.
    ● Provide support and participate in on-site audits / inspections conducted by external sources (i.e. Health Canada)
    ● File and assist with production batch records/related paperwork based on the production schedule.
    ● Assist in establishing Process Validation, Cleaning Validation and Method Validation programs to ensure production consistency.

ROLE REQUIREMENTS

  • Degree or technical diploma in a relevant field (i.e. pharmaceutical, biotechnology, science, chemistry, microbiology and biology).
    ● Minimum 1 year of experience in a relevant field (i.e. pharmaceutical, biotechnology, science, chemistry) Skills & Abilities
    ● QA experience in a GPP/GMP-focused quality related position in food, pharmaceutical or cannabis industry environment or equivalent.
    ● Experience in preparing and writing Standard Operating Procedures, Quality Management System documentation.
    ● Excellent verbal and written communication skills; and ability to clearly communicate requirements and provide direction to others in a manner that can be easily understood.
    ● Excellent organization skills and the ability to adapt to changing priorities and deadlines.
    ● Analytical thinker with excellent root-cause analysis and problem-solving skills.
    ● Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
    ● Must be able to maintain focus for long periods of time.
    ● Strong Batch Release expertise
    ● Fast paced environment
    ● On occasion flexible hours of work may be required

Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc

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