Description
**Part-time job: 30 hours/week**
**CW position – via personnel agency**
**Employment contract for one year with possibility to prolong**
**Direct Manager: Quality Assurance Manager**
**Accountabilities**
•Ensures adherence to EU GDP requirements and the Czech regulations in relation to Wholesale Distribution
•Maintains Quality Management System at the affiliate level in compliance with Czech regulations and Amgen standards
•Performs Quality-related activities for Czech market
•Supports regional activities to maintain quality system and executes tasks in compliance with Amgen’s Quality Management System, GMP & GDP requirements and any local applicable regulations
**Responsibilities**
•Supports QA Manager and Responsible Person to ensure that Quality Management System is implemented and maintained in compliance with the requirements of the EU GDP and applicable regulations in Czech Republic
•Ensures that documentation is accordingly processed, records are accurate and up to date and kept according to applicable requirements
•Ensures personnel involved in GDP activities are adequately trained
•Supports handling of Product Complaints, identification of Adverse Events, Medical Information enquiries and brand protection issues as well as potential counterfeit
•Supports authority inspections, audits, and self-inspections
•Makes the disposition decision of the medicinal products (including product release) to Czech market
•Manages product complaints handling and follow up
•Enables reporting to regulatory authorities per required procedures
•Performs customer and supplier qualification
•Maintains relationship and supports oversight of Logistics Service Provider
Up to 5 % travel may be required for meetings and training
**Minimum Requirements**
•University Degree in Pharmacy, Chemistry or Medicine
•Fluency in Czech and English languages
**Preferred Requirements**
•2 or more years of relevant work experience within the pharmaceutical industry, preferably at international company
•Experience in quality assurance and quality management
•Knowledge and understanding of the Czech regulations and European Pharmaceutical Directive related to Distribution of Medicinal Products, Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP), EU Medical Device Regulation as well as EU Falsified Medicines Directive
•Experience in supporting of regulatory inspections and audits as well as self-inspections
•Experience in records management and providing support as well as resolving and documenting investigations to support GDP tasks
•Good communication skills (Czech and English) technical writing and verbal communication/presentation
•Effective interaction with variety of communication and working styles and teams
•Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
