Quality Specialist

UCB Pharma A.Ş.

A Global Biopharma Leader 
UCB is a public traded company, listed on Euronext Brussels. UCB has transformed itself over recent decades into a world class research company in the fields of producing chemical and pharmaceuticals products for specialists; specializing in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders and oncology. In 2004, UCB acquired the leading UK-based biotechnology specialist company, Celltech Group and became one of the leading biopharmaceutical companies in the world. UCB employs over 8,500 people operating in over 40 countries.

QUALIFICATIONS·     

• University degree (in Pharmacy or Chemical Engineering),
• 1-3 years of experience in pharma industry, (preferably in production and/or quality assurance and/or quality control areas)
• Advanced English level,
• Advanced knowledge in MS Office applications,
• High interpersonal, communication and presentation skills,
• High degree of problem solving and analytical thinking skills,
• No military obligation for male candidates

JOB DESCRIPTION

• Responsible for quality document management at the affiliate.
• Archiving of quality documents (process validation, stability etc.)
• Revision and translation of quality procedures in electronic documents management system
• Documentation and tracking of all action items of complaints, deviations, CAPA and change controls in systems
• Preparation of trend reports and presentations of quality indicators
• Management of vendor qualification dossiers, quality agreements, etc.
• Collecting Quality Documentation from vendors such as; Elemental Impurity, TSE/BSE declarations, etc.
• Preparing risk assessment reports for all vendors
• Maintenance of annual audit plan and approved vendor list
• Performing local vendor audits
• Documentation and follow-up of quality KPIs of vendors
• Support warehouse quality operations including, computerized system errors, good receipt and batch release