Quality Assurance Associate and A-QPIC

JOB SUMMARY

The Quality Assurance Associate (Infusion & Compounding Pharmacy) and A-QPIC (Controlled Drugs), under the direction of the Manager, Quality & Risk Management, will support the implementation and maintenance of GxP Quality Systems and participate in quality improvement initiatives, and develop policies, procedures, and education materials to support the business.

The incumbent will support the assigned business lines with GMP, A-QPIC and DPP related Quality activities in line with respective regulations outlined by Health Canada and College of Pharmacy. Occasionally, this position may provide support to other business lines as deemed appropriate by the Quality Management team.

Work Arrangement: This role requires on-site presence, as it also carries responsibilities as the Alternate Qualified Person in Charge (A-QPIC), which requires on-site verification of processes and completion of required signoffs for narcotic products.

DUTIES AND RESPONSIBILITIES

·     Participates in the development, implementation and maintenance of Quality Management System, Document Management System and Learning Management System.

·     Responsible for ensuring compliance with Health Canada requirements for controlled drugs under the Controlled Drugs and Substances Act (CDSA) and Narcotic Control Regulations, as well as compliance with Medical Device Establishment License (MDEL) requirements as a distributor, including oversight of complaint handling, incident reporting, recalls, required records, and inspection readiness.

·     Acts as a back-up for QPIC. Maintains QA and A-QPIC oversight of processes for receiving, storing, compounding, dispensing, transporting and destroying controlled drugs.

·     Authors and participates in review/approval of SOPs related to controlled substances/ Medical Device regulations and ensure strict document control.

·   Oversees inventory reconciliation, discrepancy investigations and complete controlled drugs monthly Health Canada reporting (Monthly Activity Report-MAR) requirements.

·     Performs security, access control and chain-of-custody measures for controlled drugs.

·     Reviews batch records for compounded controlled drugs to ensure compliance with approved formulations and requirements.

·     Leads investigations and CAPA for incidents involving controlled or hazardous drugs.

·     Prepares for and support internal audits, spot audits and Health Canada inspections.

·     Supports quality oversight of hazardous and cytotoxic drugs, including safe handling, cleaning, PPE use and environmental controls.

·   Ensures compliance with NIOSH and applicable provincial OHS requirements for hazardous drugs.

·     Provides training and competency oversight for staff handling controlled or hazardous drugs.

·     Conducts Policy, SOP and Work Instruction reviews and revisions, participates in the development of new policies, procedures, and SOPs, and performs their efficacy analysis. Helps ensure appropriate training assignments on rolled-out policies, procedures, and SOPs, including proper communication to all employees.

·     Supports management of Quality Events (QEs) and deviations. Conducts root cause analysis, investigations and ensures the CAPA plan is effective and closes on time. This will require education, coordination, and collaboration across the team with all internal stakeholders. Assists with quality event trends analysis and resulting improvement initiatives.

·     Identifies training needs, participates in the development of training materials, and leads training to meet quality management standards and contractual requirements.

·     Educates internal stakeholders on key quality deliverables and identifies process improvements to increase efficiency, effectiveness, and quality.

·     Liaises with Quality leads from other business lines to collaborate on initiatives or adapt mutually beneficial processes.

·     Performs other duties as assigned.

QUALIFICATIONS

EDUCATION

• Master's degree in a scientific discipline is highly preferred but at a minimum possess bachelor's degree in chemistry, biology or in health sciences.
•  ASQ Quality certification, ISO Quality Management or Medical Devices or Auditor certification, or equivalent Quality/Pharmaceutical Sciences/Regulatory certification from an accredited institution is required.
• Completion of Quality Management, Risk Management, or related courses is preferred.

EXPERIENCE

·     At least 5 years of experience in quality assurance, preferably in the healthcare, medical devices or life sciences industry.

·     Experience of working under Health Canada's CDSA, Narcotic Drug Regulations and experience with controlled drug handling, storage, and chain-of-custody processes.

·     Proven experience conducting inventory reconciliation and resolving discrepancies involving controlled drugs.

·     Experience in the development of policies, SOPs and Work instructions as per OCS and MDEL regulations.

·     Previous experience of working with Health Canada's Medical Device Regulations (SOR/ and HC-MDEL requirements for importers and distributors, MDEL renewals and amendments.

·     Experience of maintaining compliance with MDEL obligations such as complaint handling, incident reporting, recalls and record-keeping.

·     Experience preparing for or supporting Health Canada MDEL & OCS inspections, including documentation readiness and CAPA response.

·     Experienced in using quality systems like QMS, DMS, LMS, as well as ERP & CRM applications.

·     Experience working with hazardous drugs (Cytotoxic, NIOSH-listed products) under proper safety and containment guidelines.

OTHER SKILLS AND ABILITIES

·     Strong interpersonal skills and ability to work independently and as part of a team.

·   Proven ability to build consensus and lead new initiatives.

·     High attention to detail for reconciliation and record accuracy.

·     Demonstrated ability and competency in Microsoft LMS, DMS and QMS software.

·     Exceptional organizational skills and ability to meet deadlines.

·     Strong commitment to continual learning.

·     Good analytical skills for investigating discrepancies.

·     Ability to handle confidential and sensitive information responsibly.

·     Ability to grasp the essence of issues, deal comfortably with ambiguity, and make high- quality decisions quickly.