Description:
Quality Assurance Specialist
This position requires extensive collaboration and interaction with both internal cross-functional teams The core objective is to ensure that all activities related to product quality and distribution fully comply with cGMP / GDP.
KEY RESPONSIBILITIES:
The responsibilities of this position may include, but are not limited to, the following:
- 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 (QMS).
- Ensure that 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 Commercial products for sale to the Market.
- Support the maintenance of the 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 amendment based on review comments, collection of approval signatures
- File quality records according to 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.
MINIMUM QUALIFICATIONS / SKILLS:
- Degree in pharmacy, chemistry, medicine, biology, or a related life science.
- 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.
Pay Range:
dependent upon experience