About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. The Affiliate QA Specialist is responsible for providing quality assurance support for quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with corporate, governmental, and local regulations and requirements. Responsibilities: Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products. 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 quality events (quality defects, security events, recalls etc) in the affiliate. Assist project teams in planning, preparation, review and approval of quality documentation. 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. Establish training requirements related to Quality Systems and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance. Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions. To deal with Regulatory bodies as required through using complaint reporting processes. To maintain and operate QA complaints system for both imported and manufactured products and prepare suitable customer replies. To initiate investigation with manufacturers and to ensure suitable investigations are carried out on complaint samples. Ensure all complaints are logged and acted upon to a successful conclusion. Quality management of supplier qualification program including performance monitoring for key suppliers and update of Quality Technical Agreements. Coordinate the Quality Management Review process at the affiliate. Responsible for carrying out a quality self-inspection program within the affiliate. Execute quality plans and provide assistance to the various multi-disciplinary departments and teams with respect to planning and execution. Ensure metrics and KPIs are being met. Coordinate change control process to ensure changes do not introduce adverse impact to operation. Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments. Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management. To act as Responsible Person and fulfill duties as laid out in cGDP Regulations and AbbVie Global Procedures. Responsibilities – Responsible Person Czech Republic: Ensure that a QMS is implemented and maintained (all GDP related activities are clearly defined and systematically reviewed; responsibilities processes and risk management principles in relation to distribution activities are clearly specified; the quality system is fully documented, and its effectiveness is monitored). Focus on the management of authorized activities and the accuracy and quality of records. Ensure that initial and continuous training programs are implemented and maintained. Responsible for coordinating and promptly performing any recall operations for medicinal products. Ensure that relevant customer complaints are dealt with effectively. Ensure that suppliers and customers are approved. Approve subcontracted activities which may impact GDP Ensure that self-inspections are performed at appropriate, regular intervals following a prearranged program and necessary corrective measures are put in place. Keep appropriate records of any delegated duties. Decide on the final disposition of returned, rejected, recalled or falsified products. Approve returns to stock further to internal Quality assessment. Ensure that additional requirements imposed on certain products by National law are adhered to (Distributor reporting in imports, consumptions and exports). Ensure fulfilment of requirements as per National legislation requirements in regard to Wholesaler license (Act 378/2007 and Decree 229/2008). Ensure inspection of incoming goods and release to local market. Ensure that sample management is performed according to the GDP rules and all local requirements including the relevant trainings of sales representatives are followed. Coordinate change control process to ensure changes do not introduce adverse impact to operation. Act as Responsible Person [RP] Deputy for the Slovakia Affiliate. Qualifications University Degree in Pharmacy 3+ 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. Comprehensive knowledge of national and EU GDP legislation Knowledge of Quality systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred. Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively. Strong oral and written communication skills. Proficiency in English and Czech languages. Excellent interpersonal skills. Strong computer skills Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.