Senior Associate Quality Assurance
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Job Location:
Prague - Czech Republic
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Career Category
QualityJob 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 Amgens 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 Czechand 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
Required Experience:
Senior IC
Key Skills
- Administrative Skills
- Core Java
- Glass
- Administration Support
- Database Administration
- Import & Export
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
