AbbVie Quality Assurance Manager in Wavre, Belgium
Quality Assurance Manager
Belgium, Walloon Brabant, Wavre
The QA Manager is responsible for providing quality assurance support for the quality system requirements for Belgium and Luxembourg associated with: pharmaceutical products, medical devices, combination products and biologics. This position is responsible for all product, process or system related quality activities supporting the business from receipt of final product through final product release of finished goods based on approved specifications and in compliance with Corporate, governmental and local regulations and requirements. Areas of support may also include Storage and Distribution, Supplier Controls, Product Quality Complaints, Potential Quality Events/Pproduct Shortage Execution, Product Quality Review, Risk Management, Agency Inspections/Internal Audits, CAPA, and overall Quality Manual requirements.
Act as responsible person GDP and Materiovigilance Contact Point
Ensures integration and support of quality regulations: drug, biologics, device and/or combination products.
Work independently, review and release of final product based on approved specifications, regulations and local requirements.
Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Evaluate, analyze and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.
Partner, coordinate and support activities related to product actions in the affiliate.
Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
Coordinate and investigate quality events such as deviations, non-conformances, product quality complaints and corresponding action plans including decisions.
Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature, cold chain shipments
Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management.
Required Education / Knowledge / Experience
Comply with the requirements as described in Art. 95.§2. of the R.D. of 14 Dec 2006 on ‘Geneesmiddelen voor menselijk en diergeneeskundig gebruik’:
This person holds a degree of pharmacist or master in pharmaceutical sciences, medical doctor or master in medical sciences, veterinary or master in the veterinary sciences, chemist or master in chemistry, biologist or master in biology, biomedical scientist or master in the biomedical sciences.
5+ years’ experience in quality assurance, quality oversight or relevant experience.
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
Knowledge and familiarity with product, process, and both internal and external customer requirements.
Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache, Attache Pro.
Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
Experience working in both team setting and independently.
Ability to make operational and business decisions with minimal direction.
Strong oral, written communication and presentation skills. Proficiency in Dutch/French/English.
Excellent interpersonal skills.