Quality Assurance Senior Specialist (Contract)
- Ontario
- Permanent
- Full-time
- Take ownership and provide support on QMS processes (Deviations, CAPA & Change Controls), including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
- Support the intake, triage, and logging of deviations & distribution complaints into the Veeva electronic Quality Management System (VeeQMS).
- Ensure that Canadian quality system documents, SOPs, Quality Agreements, SMFs, are compliant, up to date and accurate.
- Liaise with relevant stakeholders to obtain full information to initiate investigation and root cause analysis as per Vertex procedures. Track completion and closure in a timely manner.
- Prepare materials for distributor sites to monitor performance on deviations, cascade information and follow up on outstanding items.
- Manage the release and Batch certification of all the Vertex Canada Commercial products for sale to the Canadian Market.
- Support MQ with SOP processing through Veeva.
- Support the maintenance of the Vertex Canada Drug Establishment License.
- Raise risks/issues with timelines and seek support in timely resolution.
- Support change control records as required and complete any quality actions assigned.
- Prepare relevant QMS data reports/KPIs on Deviations, CAPA, Change Controls and Effectiveness checks, for Affiliate QMRs, inspections, ad hoc data requests and other governance meetings.
- Support creation of, and update to, Quality Agreements with Vertex Canada and external vendors by drafting using global templates, collation and amendment based on review comments, collection of approval signatures via DocuSign & upload to the VeeDMS system.
- File quality records according to Vertex records retention policy and procedures.
- Support internal audit or external audit programs and inspection readiness activities, as well as tracking post-inspection readiness.
- Support GDP operational quality in gathering relevant documentation for disposition on temperature excursions.
- Support Self-Inspections, preparation, performance, and closure of deficiencies identified.
- Support products Recall in Canada and annual Mock Recall as per the Global schedule.
- Must be a resident of Canada.
- Bachelor's Degree, preferably in life sciences or a technical discipline.
- Expertise in GxP Regulations, demonstrated working knowledge and practical application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). This includes deep familiarity with Canadian, US and international/global regulatory requirements and associated guidance documents and standards across diverse modalities (e.g., small molecule, device, biologics, cell & gene therapy).
- Direct experience with the GMP release of pharmaceutical products
- Excellent organizational and time management skills, and able to demonstrate flexibility and adaptability.
- Able to prioritize workload, decisive thinker, able to work within agreed timescales.
- Highly adaptable and flexible, with the ability to thrive in a fast-paced environment and consistently act with urgency.
- Proactive approach and strong critical thinking skills.
- Excellent verbal and written communication skills with a high level of attention to detail.
- Utilizes available digital tools and systems to enhance QA performance and efficiency.
- Ability to collaborate cross-functionally across all levels of the organization.
- Ability to drive results.
- Continuous Process improvement mindset.
- Degree in pharmacy, chemistry, medicine, biology, or a related life science.
- GDP & GMP work experience, or relevant comparable background.
- Experience with processing deviations and CAPA in an electronic QMS tool such as Veeva or equivalent.
- Fluency in English is required.
- Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint).