Job Description
Senior Quality Assurance Specialist will be responsible for monitoring and maintaining all aspects of the Quality Management System for DEX Medical Distribution Inc. (DEX) and Pharmacy Business Units (BUs) within the Bayshore Specialty Rx (BSRx) division. The Senior Quality Assurance Specialist is responsible for ensuring site compliance with all federal and local regulations (as applicable) as well as internal policies and procedures. Additionally, the incumbent is responsible for maintaining oversight of activities carried out by the Qualified Person-In-Charge (QPIC) and A/QPIC for narcotics and controlled drugs.DUTIES AND RESPONSIBILITIES:Responsible for the operation and execution of the Quality Management System relating to Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and Medical Devices Regulations (MDR) for DEX and all Pharmacy BUs within the Bayshore Specialty Rx (BSRx) division. * Define and implement quality standards, systems, and metrics for maintaining regulatory compliance as it relates to the importation, packaging/labeling, wholesale, and distribution of drug products and/or medicinal products for the Canadian market. Collaborate across the Operations and divisional Quality team to help provide support and drive various Business units (BUs) within the BSRx Division to the most compliant, quality outcomes.Be responsible for the following audit/inspection readiness-related activities:Maintain key audit/inspection readiness documents to ensure the most up-to date version and correct documents are available in the repository at all times.Co-lead the coordination of External Audits / Regulatory Inspections including but not limited to: audit scheduling, pre-audit training, logistics, audit runner, document follow-up, and drafting and tracking CAPA Plan.Support on-site internal audits from independent internal auditors.Responsible for new license applications, annual renewals, and amendments of the following licenses for DEX and BSRxDrug Establishment License (DEL)Medical Devices Establishment Licenses (MDEL)Narcotic/Controlled Substances License for ‘DEX’ and ‘BSRx’Responsible for execution of quality review, approval, and management of GMP activities including Batch Records and associated documents and processes (internal and/or external deviations, change controls, CAPAs, complaints) for importation and/or distribution of drug products and medical devices in the Canadian Market.Manages QA operations activities including creation, review, and approval of the following types of documents:Change ControlsDeviationsComplaintsCAPAsExecute investigations for deviations, complaints, temperature alarms (ambient and cold), product incidents and recalls with implementation of appropriate CAPAs.Ensure timely closure of deviations, complaints, change controls, and CAPAs.Acts as the local coordinator for Product Recall activities and manages local mock recall exercises.Tracks relevant Quality System Metrics including deviations, change controls, CAPA, complaints and recalls. Uses metrics to identify and pursue quality improvement initiatives.Presents Quality KPIs to the leadership team on a set frequency.Co-lead preparation and management of Quality Agreements with the Pharmaceutical Clients and third-party subcontractors.As required, prepare new documents and/or revise existing documents such as Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs), and Forms.Oversee Vendor Qualification/Management process, assess the risk, and approve subcontractors from a quality standpoint.Responsible for review and approval of validation documents forWarehouse Temperature MappingEquipment such as shippers, refrigerators, and freezers.Oversee the delivery and completion of annual GxP training to ensure compliance with internal policies and contractual obligations.Establish and maintain effective working relationships with both internal and external stakeholders that promote continuous application of quality principles and compliance with regulatory requirements while remaining independent.Mentors QA colleagues and takes interest in their growth and development.Educates internal operations team members on quality principles.Acts as a back-up for other Quality personnel supporting Dex and other Pharmacy BUs within BSRx.QualificationsEDUCATION:Bachelor’s degree in Life Sciences or related field (Chemistry, Biology, or Pharmacy) is a must. Quality and/or Regulatory Affairs Certification is highly desirable (ISO, SOP, GMP related programs).Supply Chain certification is considered an assetEXPERIENCE:At least 5 years of previous experience working in the Healthcare field in a Quality role.Knowledge of Health Canada GMP (Good Manufacturing Practices), ICH (International Conference on Harmonization), GDP (Good Documentation Practices), ASQ, and ISO guidelines.Familiar with pharmaceutical equipment, utilities, and validation concepts.Experience with document life cycle management and document change control management.Experience working with quality management systems and document management systems.Excellent analytical, observation, and problem-solving skills.High sense of energy & urgency with a positive attitude.Exemplary oral and written communication skills and written document skills.OTHER SKILLS AND ABILITIESAbility to thrive and lead in a cross-functional environment (matrix organization) and promote collaboration.Ability to grasp the essence of issues, deal comfortably with ambiguity, and make high quality decisions quickly.Ability to resolve conflict with tact and diplomacy.Ability to successfully coach, mentor and provide ongoing quality and compliance education.Advanced computer skills in MS Word, MS Excel, MS PowerPoint, MS Publisher, MS Outlook, and the ability to learn other software/applications as required.