Quality Compliance Specialist: Technical Writer (f/m/x), HybridVienna, Vienna
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
About the role:
Are you interested in a position that combines learning a lot about the manufacturing processes on site and working in teams making sure that submissions are written accurately and on time? Are you a well organized and responsible person, who will represent the site to deliver high quality submissions for our patients? Then make sure to apply, we are looking forward to it.
How you will contribute:
Preparation, coordination and update of production documentation for CMC regulatory submissions
Preparation and review of documentation related to chapters describing production, processes and facilities & equipment, process validation and equipment qualification
Coordination between site-related functions (Production, Validation, Quality etc.), global functions (e.g. PQLs) and Regulatory Affairs
Response to questions from authorities related to above listed chapters
Preparation and maintenance of Process Reference documents (for the assessment of manufacturing deviations according to licenses) and corresponding procedure
Additional support for other chapters in CMC regulatory submissions if necessary
Support of GMP renewals/facility registration requests
Quality review and content verification of submission documents
Point of contact for the Vienna site during alignment meetings with Regulatory Affairs (different time zones)
What you bring to Takeda:
Graduated from a technical, chemical or biological college or university
At least 2 years practical experience in pharmaceutical industry (from areas such as quality assurance, validation, manufacturing etc.)
Understanding of the quality requirements in the areas of manufacturing, manufacturing science and validation
Knowledge of applicable regulations and laws for biological products, such as FDA CFR, EU GMP beneficial
Personal features: responsibility, accuracy, strong analytical skills, organizational skills, team player
Technical skills and affinity for IT
Fluent in English and German and strong communications skills
What Takeda can offer you:
A competitive remuneration package with a minimum salary of € 3.909,67 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
Work @ home depending on the position / department
Comprehensive training programs
In-house job rotation program
In-house Canteen with discounts or meal vouchers
Works council (events, festivals, shopping vouchers, etc.)
Employee Referral Program
Employee Recognition Program
Takeda Resource Groups
Free vaccination program
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
LocationsAUT - Wien - Industriestrasse 67
Time TypeFull time
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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