Sr. Spclst, Quality Assurance

Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that is devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Our site in 1210 Vienna is a strategic location for solid drug manufacturing including tablets, coated tablets, granules and implants for the health provision and treatment of livestock and domestic animals. Most of our products are exported. To ensure sustainable company growth we continually strive to offer attractive career opportunities for more than 450 employees at our Vienna site. In support of our existing team, we are currently looking for a:

• Usage Decision for Bulk, FPU and FPP based on product specific training
• Assure that each batch was manufactured according to GMP and all other applicable regulations including respective marketing authorization
• Issue CoAs and CoCs for Bulk, FPU and FPP

• Assess product quality related deviations and CAPAs
• Assess product impact in change control
• Manage, review and approve product quality complaints
  Review and approve product quality reports
• Manage QP and QAO related document creation, review and approval
• Product Quality support in site and global projects

• Contribute to Inspection Readiness for the Vienna site
• Attend conferences and trainings as required to maintain proficiency
• Compliance with EHS regulations, reporting of dangerous situations, near misses and sources of danger in the working environment
• Compliance with our ethical guidelines and global standards as applicable 

• Perform any other duties as assigned management on an as-needed basis

• Master’s degree in scientific education
• QP certification
• Significant work experience in quality department and GMP knowledge
• Strong knowledge of regulatory and governance requirements
• Understanding of product quality and compliance
• Broad industry knowledge
• Excellent internal and external communication skills
• Strong written and verbal communication skills in German and English
• Solid organizational and planning skills
• Strong problem-solving and analytical abilities
• Good judgment, discipline, and confidence 

Current Employees apply HERE

Current Contingent Workers apply HERE