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Senior Specialist Quality Assurance, Qualified Person
vor 1 Monat
Job Description
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
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:
Senior Specialist Quality Assurance, Qualified Person (m/f/d)
Main Responsibilities:
- Qualified Person according to Austrian "Arzneimittelbetriebsordnung 2009" and EU Guide to Good Manufacturing Practice Annex 16
- Batch Release: 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
- Review and approve product quality reports
- Manage QP and QAO related document creation, review, and approval
- 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
Requirements:
- Master's Degree in Scientific education
- Qualified Person (QP) certification, according to Austrian "Arzneimittelbetriebsordnung 2009" and EU Guide to Good Manufacturing Practice Annex 16
- Significant work experience in quality department and GMP knowledge Regulatory and governance
- Product Quality and compliance knowledge
- Excellent written and verbal communication skills (German & English)
- Solid organizational skills, problem-solving, and analytical skills
We offer an attractive salary, outstanding social benefits, and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 61.300, - and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: No Travel Required
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 04/7/2025
*A job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R337520
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